CancerNCT03743415
Caregivers' and Cancer Survivors' Psychological Distress & Symptom Management
A study testing Handbook and TIP-C plus Handbook in people with Cancer, run by University of Arizona at 1 site in United States.
Trial summary
Sample: The sample will be 298 ethnically diverse (30% Hispanic) survivors who have a new diagnosis or localized recurrence of solid tumor cancer and elevated depression or anxiety and their informal caregivers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Handbook and TIP-C plus Handbook
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 908 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2019to 27 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inclusion criteria for the survivors are: 1) age 18 or older; 2) undergoing chemotherapy, hormonal therapy, or targeted therapy for a solid tumor cancer; 3) able to perform basic activities of daily living; 4) cognitively oriented to time, place, and person (determined by recruiter); 5) reporting severity of >2 on depression or >4 on anxiety using a 0-10 standardized scale; 6) able to speak and understand English or Spanish; 7) access to a telephone and 8) has a caregiver who can be in any relationship role (e.g., spouse, sibling, parent, friend) who can participate with them.
- Inclusion criteria for the caregivers are: 1) age 18 or older; 2) able to speak and understand English or Spanish; 3) access to a telephone; 4) not currently receiving counseling and/or psychotherapy; and 5) not currently treated for cancer.
Who cannot join
- Exclusion criteria are: 1) diagnosis of a psychotic disorder in the health record; 2) nursing home resident; 3) bedridden; 4) currently receiving counseling and/or psychotherapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arizona Cancer Center
Tucson, Arizona, 85721
About this study
Official title: Improving Informal Caregivers' and Cancer Survivors' Psychological Distress, Symptom Management and Health Care Use
Sample: The sample will be 298 ethnically diverse (30% Hispanic) survivors who have a new diagnosis or localized recurrence of solid tumor cancer and elevated depression or anxiety and their informal caregivers. Design: The investigators selected the SMART design for this study over alternative designs (e.g.,implementation designs) because the SMART design allows a precision or personalized approach to determine the right treatment at the right dose with the right sequence for the right survivor-caregiver dyad. SMART designs, although newer, show promise in developing the sequences of evidence-based interventions for more efficient and individualized patient- and caregiver-centered care. The investigators will use findings from this study to create an algorithm for clinically meaningful decision making about symptom management for survivors and their caregivers to be tested in future implementation/dissemination studies. The dyad (survivor-caregiver) will be randomly assigned to either: 1) Symptom Management and Survivorship Guideline (Handbook) alone or 2) Telephone Interpersonal Counseling (TIP-C) +Handbook for 8 weeks followed by continued Handbook alone for 4 weeks. During 12 weeks following initial randomization, all participants will receive weekly telephone contacts to assess symptoms, deliver the assigned intervention and assess its enactment and fidelity. After the initial 4 weeks in the Handbook alone group, the survivor's response to the intervention will be determined. If the survivor responds (defined as a reduced score on depression and/or anxiety), the dyad will continue with the Handbook alone for 8 more weeks. If the survivor is a non-responder (defined as no improvement or a worsening score for depression and/or anxiety), the dyad will be re-randomized to either continue with Handbook alone for 8 more weeks, or add 8 weeks of TIP-C. Outcomes will be assessed at baseline, weeks 13 and 17 for both members of the dyad.
Read the detailed description
Informal caregivers, typically family members or friends, provide more than half of the care needed for the 5.7 million cancer survivors (defined as individuals from diagnosis to end-of-life) in the United States, often with negative consequences to their health. Caregivers assist with the management of the survivor's symptoms such as fatigue, pain and insomnia, and others.Psychological distress (depression and anxiety) has been reported in at least 30% of survivors and their caregivers who are not always prepared for the task of symptom management. This research assists both the caregiver and survivor (the dyad in this study) to manage the survivor's cancer- and treatment-related symptoms and the distress of both members of the dyad in a sample of 298 survivors with elevated depression or anxiety and their 298 caregivers. Dyads will be recruited during the survivor's chemotherapy or targeted therapy for a solid tumor, a time when symptom burden and psychological distress are particularly high.
The investigators will use two evidence-based interventions extensively tested against active and passive controls in traditional randomized controlled trials (RCTs). While overall efficacy of these interventions has been established, individuals differ in their responses. When an intervention does not initially work, clinical logic is to either extend the timeframe or prescribe a different intervention. Yet, these alternatives are seldom tested and not evidence-based. The proposed project advances beyond a traditional RCT of testing fixed "one size fits all" interventions to the sequential multiple assignment randomized trial (SMART) design to build the evidence base for intervention sequencing that accounts for heterogeneity of responses.
The first intervention, a printed symptom management and survivorship handbook (Handbook) with strategies for self-management of symptoms common during chemotherapy will be given to both survivor and caregiver (the dyad). Handbook strategies, if successfully enacted, produce positive symptom responses for the survivor. However, psychological distress of the survivor or the caregiver may diminish the receipt and enactment of the Handbook strategies and also exacerbate the severity of other symptoms which, in turn, produces poor symptom responses. Research by this team has documented dyadic effects where survivors' psychosocial distress impacts that of the caregiver and vice versa. The survivor's and caregiver's distress exhibit similar trajectories. Therefore, the second intervention tested in sequencing is the 8-week telephone interpersonal counseling intervention (TIP-C) to manage psychological distress of the dyad.
The dyad (survivor-caregiver) will be randomly assigned to either: 1) Symptom Management and Survivorship Guideline (Handbook) alone or 2) Telephone Interpersonal Counseling (TIP-C) +Handbook for 8 weeks followed by continued Handbook alone for 4 weeks. During 12 weeks following initial randomization, all participants will receive weekly telephone contacts to assess symptoms, deliver the assigned intervention and assess its enactment and fidelity. After the initial 4 weeks in the Handbook alone group, the survivor's response to the intervention will be determined. If the survivor responds (defined as a reduced score on depression and/or anxiety), the dyad will continue with the Handbook alone for 8 more weeks. If the survivor is a non-responder (defined as no improvement or a worsening score for depression and/or anxiety), the dyad will be re-randomized to either continue with Handbook alone for 8 more weeks, or add 8 weeks of TIP-C. Outcomes will be assessed at baseline, weeks 13 and 17 for both members of the dyad.
The following specific aims will be tested.
- Determine if dyads in the TIP-C+Handbook as compared to the Handbook alone group created by the first randomization will have: a) lower depression, anxiety, and summed severity of 13 other symptoms at weeks 1-12, 13, and 17 (primary outcomes); b) lower use of healthcare services (hospitalizations, urgent care or emergency department [ED] visits) during 17 weeks (secondary outcomes); c) greater self-efficacy, social support, and lower caregiver burden during weeks 13 and 17 (potential mediators).
- Among non-responders to the Handbook alone after 4 weeks, determine if dyads in TIP-C+Handbook as compared to the Handbook alone group created by the second randomization will have better primary and secondary outcomes and potential mediators at weeks 5-12, 13, and 17.
- Test the interdependence in survivors' and caregivers' primary and secondary outcomes.
- Determine which characteristics of the dyad are associated with responses to the Handbook alone during weeks 1-4 and optimal outcomes for the dyad during weeks 1-12, 13 and 17 so as to determine tailoring variables for the decision rules of individualized sequencing of interventions in the future.
- Conditions
- Cancer
- Being tested
- Handbook, TIP-C plus Handbook
- Keywords
- psychosocial oncology, symptom management
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HandbookBehavioural
Also called Symptom Management and Survivorship Handbook
see arm/group descriptions
TIP-C plus HandbookBehavioural
Also called Telephone Interpersonal Counseling plus Handbook
see arm/group descriptions
| Study group | Role | What they receive |
|---|---|---|
| Handbook | Experimental | The Symptom Management and Survivorship Handbook is a self-care management handbook with each symptom chapter presented in an identical format: what the symptom is, how people describe the symptom, the causes of the symptom, strategies for managing the symptom and resources. The Handbook is available in English and Spanish. Each weekly call will begin with the symptom assessment. For each symptom rated at 4 or higher on a 0-10 scale of severity, the survivors will be referred for symptom self-management. During weeks 2-12, Handbook use since the last call (intervention enactment) and symptoms will be assessed. During weekly calls to caregivers, the caregivers will be notified of symptoms above threshold experienced by survivors and directed to the Handbook. During weeks 2-12, Handbook use and symptoms are assessed, a summary of survivors' symptoms provided. Calls will last about 10 minutes. Receives: Behavioral: Handbook |
| TIP-C plus Handbook | Experimental | Each survivor and caregiver will receive one 40-minute telephone call per week for 12 weeks. The Telephone Interpersonal Counseling (TIP-C) intervention 8-week protocol is the same for both survivor and caregiver. During weekly contacts, the counselors target social support behaviors using interpersonal communications techniques. Counselors can personalize the counseling intervention for the specific needs or interests as expressed during sessions while still adhering to a structured protocol. The final 4 weeks will be Handbook only. Receives: Behavioral: TIP-C plus Handbook |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom Severity Index- Comparison of Two Groups Created by First Randomization
Symptoms were measured using the modified General Symptom Distress Scale (GSDS), a brief instrument that measures 18 common symptoms fatigue, sleep difficulties, pain, headache, difficulty concentrating, lack of appetite, nausea, vomiting, constipation, diarrhea, numbness or tingling, skin rashes or sores, swelling, weakness, shortness of breath, cough, depression, and anxiety. Respondents indicate severity of each symptom on the scale from 0=not present to 10=worst possible. A summed symptom severity index for 16 symptoms other than depression and anxiety was computed by adding severities of 16 symptoms at each weekly contact (weeks 1-12) and week 13 interview for the immediate effects. The summed symptom severity range is 0-160, a higher score reflects a worse outcome. Week 17 value of the index was analyzed to determine the sustained effects.
Measured: Weeks 1-13 and week 17
Symptom Severity Index- Comparison of Two Groups Created by Second Randomization
Symptoms were measured using the modified General Symptom Distress Scale (GSDS), a brief instrument that measures 18 common symptoms fatigue, sleep difficulties, pain, headache, difficulty concentrating, lack of appetite, nausea, vomiting, constipation, diarrhea, numbness or tingling, skin rashes or sores, swelling, weakness, shortness of breath, cough, depression, and anxiety. Respondents indicate severity of each symptom on the scale from 0=not present to 10=worst possible. A summed symptom severity index for 16 symptoms other than depression and anxiety was computed by adding severities of 16 symptoms at each weekly contact (weeks 5-12) and week 13 interview for the immediate effects. The summed symptom severity range is 0-160, a higher score reflects a worse outcome. Week 17 value of the index was analyzed to determine the sustained effects.
Measured: Weeks 5-13 and week 17
Secondary outcomes (4)
Depressive Symptoms- Comparison of Two Groups Created by First Randomization
Measured using Center for Epidemiological Studies- Depression (CES-D) 20-item scale. Potential score range is 0-60. Higher scores indicated worse outcome (higher depressive symptoms).
Measured: Week 13 and week 17
Depressive Symptoms- Comparison of Two Groups Created by Second Randomization
Measured using Center for Epidemiological Studies- Depression (CES-D) 20-item scale. Potential score range is 0-60. Higher scores indicated worse outcome (higher depressive symptoms).
Measured: Week 13 and week 17
Anxiety Symptoms- Comparison of Two Groups Created by First Randomization
Measured using Patient-Reported Outcomes Measurement Information System (PROMIS)-Anxiety 8a short form. Each question is rated on a five-point scale from 1=Never to 5=Always. The lowest possible raw score is 8; the highest possible raw score is 40. Raw scores are converted into t-scores with potential range of 37.1 to 83.1. Higher scores indicate greater anxiety. The mean of the US general population is 50 with standard deviation 10. Consensus-based but not data-based thresholds for scores in cancer populations are 50 for mildly symptomatic, 60 for moderately symptomatic, and 70 for severely symptomatic.
Measured: Week 13 and week 17
Anxiety Symptoms- Comparison of Two Groups Created by Second Randomization
Measured using Patient-Reported Outcomes Measurement Information System (PROMIS)-Anxiety 8a short form. Each question is rated on a five-point scale from 1=Never to 5=Always. The lowest possible raw score is 8; the highest possible raw score is 40. Raw scores are converted into t-scores with potential range of 37.1 to 83.1. Higher scores indicate greater anxiety. The mean of the US general population is 50 with standard deviation 10. Consensus-based but not data-based thresholds for scores in cancer populations are 50 for mildly symptomatic, 60 for moderately symptomatic, and 70 for severely symptomatic.
Measured: Week 13 and week 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start16 Jan 2019
- Primary completion27 May 2022
- Study completion27 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- This project will determine which dyads require which intervention sequence: Handbook alone, Handbook alone stepped up with Telephone Interpersonal Counseling (TIP-C) based on demonstrated needs after giving Handbook alone 4 weeks of time, or an combined TIP-C+Handbook for the first 8 weeks then Handbook alone for 4 weeks. Dyads will be initially randomized to either Handbook alone or TIP-C+Handbook. If the survivor's depression or anxiety does not respond to Handbook alone at week 4, dyads will be re-randomized to the TIPC+Handbook or continue with Handbook alone. Outcome data will be collected at baseline, weeks 13 (post-intervention) and 17 (follow-up). Total duration is 17 weeks.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 908 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Terry Badger, PhD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03743415
- Sponsor's protocol ID
- 1804501501
- Other IDs
- R01CA224282
- Status last verified
- Nov 2023
- First submitted
- 20 Jul 2018
- Last updated
- 29 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators will share the findings and data with other researchers, the public, and key stakeholders based on the principles that NIH has articulated regarding the sharing of study results and resources. The University of Arizona agrees that data sharing is essential for expedited translation of research results into knowledge, products, and procedures to improve health. Sharing of study results Manuscript based on results from the proposed study will be published in peer-reviewed journals. The investigators will select "open access" options for these manuscripts whenever possible. Data Sharing Data from this study will be available to other researchers under the following conditions: 1) appropriate human subjects protection is in place; 2) data have been de-identified; and 3) study investigators have publicly presented and published key findings. Data and safety monitoring plan is described under Human Subjects.
Publications
Warner EL, Traslavina Jimenez J, Sikorskii A, Segrin C, Crane T, Badger TA. Feedback on Adapting Interventions for AYA Cancer Survivors' and Caregivers' Psychological Distress, Symptom Management, and Health Care Use. J Adolesc Young Adult Oncol. 2026 Apr;15(2):134-142. doi: 10.1177/21565333251369687. Epub 2025 Dec 11.
PubMed 40828682Warner EL, Sikorskii A, Cunicelli N, Badger T, Segrin C, Morrill KE, Rainbow J. Employment Productivity and Cancer-Related Psychological Symptoms Among Adult Cancer Dyads. J Occup Environ Med. 2025 May 1;67(5):e294-e301. doi: 10.1097/JOM.0000000000003334. Epub 2025 Jan 30.
PubMed 39905918Badger T, Segrin C, Crane TE, Chalasani P, Arslan W, Hadeed M, Given CW, Sikorskii A. A sequential multiple assignment randomized trial of symptom management for cancer survivors during treatment and their informal caregivers. Support Care Cancer. 2024 Jul 18;32(8):523. doi: 10.1007/s00520-024-08734-6.
PubMed 39023547Badger T, Segrin C, Crane T, Morrill K, Sikorskii A. Social determinants of health, psychological distress, and caregiver burden among informal cancer caregivers of cancer survivors during treatment. J Psychosoc Oncol. 2024;42(3):333-350. doi: 10.1080/07347332.2023.2248486. Epub 2023 Aug 23.
PubMed 37609806
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Informal Caregivers' and Cancer Survivors' Psychological Distress, Symptom Management and Health Care Use
- ClinicalTrials.gov ID
- NCT03743415
- Acronym / sponsor ID
- 1804501501
- Conditions
- Cancer
- Keywords
- psychosocial oncology, symptom management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 908 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 16 Jan 2019 (actual)
- Primary completion
- 27 May 2022 (actual)
- Study completion
- 27 May 2022 (actual)
- First posted
- 16 Nov 2018 (actual)
- Results
- Posted 29 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sample: The sample will be 298 ethnically diverse (30% Hispanic) survivors who have a new diagnosis or localized recurrence of solid tumor cancer and elevated depression or anxiety and their informal caregivers. Design: The investigators selected the SMART design for this study over alternative designs (e.g.,implementation designs) because the SMART design allows a precision or personalized approach to determine the right treatment at the right dose with the right sequence for the right survivor-caregiver dyad. SMART designs, although newer, show promise in developing the sequences of evidence-based interventions for more efficient and individualized patient- and caregiver-centered care. The investigators will use findings from this study to create an algorithm for clinically meaningful decision making about symptom management for survivors and their caregivers to be tested in future implementation/dissemination studies. The dyad (survivor-caregiver) will be randomly assigned to either: 1) Symptom Management and Survivorship Guideline (Handbook) alone or 2) Telephone Interpersonal Counseling (TIP-C) +Handbook for 8 weeks followed by continued Handbook alone for 4 weeks. During 12 weeks following initial randomization, all participants will receive weekly telephone contacts to assess symptoms, deliver the assigned intervention and assess its enactment and fidelity. After the initial 4 weeks in the Handbook alone group, the survivor's response to the intervention will be determined. If the survivor responds (defined as a reduced score on depression and/or anxiety), the dyad will continue with the Handbook alone for 8 more weeks. If the survivor is a non-responder (defined as no improvement or a worsening score for depression and/or anxiety), the dyad will be re-randomized to either continue with Handbook alone for 8 more weeks, or add 8 weeks of TIP-C. Outcomes will be assessed at baseline, weeks 13 and 17 for both members of the dyad.
Detailed description
Informal caregivers, typically family members or friends, provide more than half of the care needed for the 5.7 million cancer survivors (defined as individuals from diagnosis to end-of-life) in the United States, often with negative consequences to their health. Caregivers assist with the management of the survivor's symptoms such as fatigue, pain and insomnia, and others.Psychological distress (depression and anxiety) has been reported in at least 30% of survivors and their caregivers who are not always prepared for the task of symptom management. This research assists both the caregiver and survivor (the dyad in this study) to manage the survivor's cancer- and treatment-related symptoms and the distress of both members of the dyad in a sample of 298 survivors with elevated depression or anxiety and their 298 caregivers. Dyads will be recruited during the survivor's chemotherapy or targeted therapy for a solid tumor, a time when symptom burden and psychological distress are particularly high.
The investigators will use two evidence-based interventions extensively tested against active and passive controls in traditional randomized controlled trials (RCTs). While overall efficacy of these interventions has been established, individuals differ in their responses. When an intervention does not initially work, clinical logic is to either extend the timeframe or prescribe a different intervention. Yet, these alternatives are seldom tested and not evidence-based. The proposed project advances beyond a traditional RCT of testing fixed "one size fits all" interventions to the sequential multiple assignment randomized trial (SMART) design to build the evidence base for intervention sequencing that accounts for heterogeneity of responses.
The first intervention, a printed symptom management and survivorship handbook (Handbook) with strategies for self-management of symptoms common during chemotherapy will be given to both survivor and caregiver (the dyad). Handbook strategies, if successfully enacted, produce positive symptom responses for the survivor. However, psychological distress of the survivor or the caregiver may diminish the receipt and enactment of the Handbook strategies and also exacerbate the severity of other symptoms which, in turn, produces poor symptom responses. Research by this team has documented dyadic effects where survivors' psychosocial distress impacts that of the caregiver and vice versa. The survivor's and caregiver's distress exhibit similar trajectories. Therefore, the second intervention tested in sequencing is the 8-week telephone interpersonal counseling intervention (TIP-C) to manage psychological distress of the dyad.
The dyad (survivor-caregiver) will be randomly assigned to either: 1) Symptom Management and Survivorship Guideline (Handbook) alone or 2) Telephone Interpersonal Counseling (TIP-C) +Handbook for 8 weeks followed by continued Handbook alone for 4 weeks. During 12 weeks following initial randomization, all participants will receive weekly telephone contacts to assess symptoms, deliver the assigned intervention and assess its enactment and fidelity. After the initial 4 weeks in the Handbook alone group, the survivor's response to the intervention will be determined. If the survivor responds (defined as a reduced score on depression and/or anxiety), the dyad will continue with the Handbook alone for 8 more weeks. If the survivor is a non-responder (defined as no improvement or a worsening score for depression and/or anxiety), the dyad will be re-randomized to either continue with Handbook alone for 8 more weeks, or add 8 weeks of TIP-C. Outcomes will be assessed at baseline, weeks 13 and 17 for both members of the dyad.
The following specific aims will be tested.
- Determine if dyads in the TIP-C+Handbook as compared to the Handbook alone group created by the first randomization will have: a) lower depression, anxiety, and summed severity of 13 other symptoms at weeks 1-12, 13, and 17 (primary outcomes); b) lower use of healthcare services (hospitalizations, urgent care or emergency department [ED] visits) during 17 weeks (secondary outcomes); c) greater self-efficacy, social support, and lower caregiver burden during weeks 13 and 17 (potential mediators).
- Among non-responders to the Handbook alone after 4 weeks, determine if dyads in TIP-C+Handbook as compared to the Handbook alone group created by the second randomization will have better primary and secondary outcomes and potential mediators at weeks 5-12, 13, and 17.
- Test the interdependence in survivors' and caregivers' primary and secondary outcomes.
- Determine which characteristics of the dyad are associated with responses to the Handbook alone during weeks 1-4 and optimal outcomes for the dyad during weeks 1-12, 13 and 17 so as to determine tailoring variables for the decision rules of individualized sequencing of interventions in the future.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This project will determine which dyads require which intervention sequence: Handbook alone, Handbook alone stepped up with Telephone Interpersonal Counseling (TIP-C) based on demonstrated needs after giving Handbook alone 4 weeks of time, or an combined TIP-C+Handbook for the first 8 weeks then Handbook alone for 4 weeks. Dyads will be initially randomized to either Handbook alone or TIP-C+Handbook. If the survivor's depression or anxiety does not respond to Handbook alone at week 4, dyads will be re-randomized to the TIPC+Handbook or continue with Handbook alone. Outcome data will be collected at baseline, weeks 13 (post-intervention) and 17 (follow-up). Total duration is 17 weeks.
| Arm | Type | Receives |
|---|---|---|
| Handbook | Experimental | Behavioral: HandbookThe Symptom Management and Survivorship Handbook is a self-care management handbook with each symptom chapter presented in an identical format: what the symptom is, how people describe the symptom, the causes of the symptom, strategies for managing the symptom and resources. The Handbook is available in English and Spanish. Each weekly call will begin with the symptom assessment. For each symptom rated at 4 or higher on a 0-10 scale of severity, the survivors will be referred for symptom self-management. During weeks 2-12, Handbook use since the last call (intervention enactment) and symptoms will be assessed. During weekly calls to caregivers, the caregivers will be notified of symptoms above threshold experienced by survivors and directed to the Handbook. During weeks 2-12, Handbook use and symptoms are assessed, a summary of survivors' symptoms provided. Calls will last about 10 minutes. |
| TIP-C plus Handbook | Experimental | Behavioral: TIP-C plus HandbookEach survivor and caregiver will receive one 40-minute telephone call per week for 12 weeks. The Telephone Interpersonal Counseling (TIP-C) intervention 8-week protocol is the same for both survivor and caregiver. During weekly contacts, the counselors target social support behaviors using interpersonal communications techniques. Counselors can personalize the counseling intervention for the specific needs or interests as expressed during sessions while still adhering to a structured protocol. The final 4 weeks will be Handbook only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Inclusion criteria for the survivors are: 1) age 18 or older; 2) undergoing chemotherapy, hormonal therapy, or targeted therapy for a solid tumor cancer; 3) able to perform basic activities of daily living; 4) cognitively oriented to time, place, and person (determined by recruiter); 5) reporting severity of >2 on depression or >4 on anxiety using a 0-10 standardized scale; 6) able to speak and understand English or Spanish; 7) access to a telephone and 8) has a caregiver who can be in any relationship role (e.g., spouse, sibling, parent, friend) who can participate with them.
- Inclusion criteria for the caregivers are: 1) age 18 or older; 2) able to speak and understand English or Spanish; 3) access to a telephone; 4) not currently receiving counseling and/or psychotherapy; and 5) not currently treated for cancer.
Key exclusion criteria (1 listed)
- Exclusion criteria are: 1) diagnosis of a psychotic disorder in the health record; 2) nursing home resident; 3) bedridden; 4) currently receiving counseling and/or psychotherapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HandbookAlso: Symptom Management and Survivorship Handbooksee arm/group descriptions | Behavioural | Handbook |
| TIP-C plus HandbookAlso: Telephone Interpersonal Counseling plus Handbooksee arm/group descriptions | Behavioural | TIP-C plus Handbook |
Primary outcome
Symptom Severity Index- Comparison of Two Groups Created by First Randomization
Time frame: Weeks 1-13 and week 17
Symptoms were measured using the modified General Symptom Distress Scale (GSDS), a brief instrument that measures 18 common symptoms fatigue, sleep difficulties, pain, headache, difficulty concentrating, lack of appetite, nausea, vomiting, constipation, diarrhea, numbness or tingling, skin rashes or sores, swelling, weakness, shortness of breath, cough, depression, and anxiety. Respondents indicate severity of each symptom on the scale from 0=not present to 10=worst possible. A summed symptom severity index for 16 symptoms other than depression and anxiety was computed by adding severities of 16 symptoms at each weekly contact (weeks 1-12) and week 13 interview for the immediate effects. The summed symptom severity range is 0-160, a higher score reflects a worse outcome. Week 17 value of the index was analyzed to determine the sustained effects.
Symptom Severity Index- Comparison of Two Groups Created by Second Randomization
Time frame: Weeks 5-13 and week 17
Symptoms were measured using the modified General Symptom Distress Scale (GSDS), a brief instrument that measures 18 common symptoms fatigue, sleep difficulties, pain, headache, difficulty concentrating, lack of appetite, nausea, vomiting, constipation, diarrhea, numbness or tingling, skin rashes or sores, swelling, weakness, shortness of breath, cough, depression, and anxiety. Respondents indicate severity of each symptom on the scale from 0=not present to 10=worst possible. A summed symptom severity index for 16 symptoms other than depression and anxiety was computed by adding severities of 16 symptoms at each weekly contact (weeks 5-12) and week 13 interview for the immediate effects. The summed symptom severity range is 0-160, a higher score reflects a worse outcome. Week 17 value of the index was analyzed to determine the sustained effects.
4 secondary outcomes
Depressive Symptoms- Comparison of Two Groups Created by First Randomization
Time frame: Week 13 and week 17
Depressive Symptoms- Comparison of Two Groups Created by Second Randomization
Time frame: Week 13 and week 17
Anxiety Symptoms- Comparison of Two Groups Created by First Randomization
Time frame: Week 13 and week 17
Anxiety Symptoms- Comparison of Two Groups Created by Second Randomization
Time frame: Week 13 and week 17
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40828682Warner EL, Traslavina Jimenez J, Sikorskii A, Segrin C, Crane T, Badger TA. Feedback on Adapting Interventions for AYA Cancer Survivors' and Caregivers' Psychological Distress, Symptom Management, and Health Care Use. J Adolesc Young Adult Oncol. 2026 Apr;15(2):134-142. doi: 10.1177/21565333251369687. Epub 2025 Dec 11.
- Derived from this study: PubMed 39905918Warner EL, Sikorskii A, Cunicelli N, Badger T, Segrin C, Morrill KE, Rainbow J. Employment Productivity and Cancer-Related Psychological Symptoms Among Adult Cancer Dyads. J Occup Environ Med. 2025 May 1;67(5):e294-e301. doi: 10.1097/JOM.0000000000003334. Epub 2025 Jan 30.
- Derived from this study: PubMed 39023547Badger T, Segrin C, Crane TE, Chalasani P, Arslan W, Hadeed M, Given CW, Sikorskii A. A sequential multiple assignment randomized trial of symptom management for cancer survivors during treatment and their informal caregivers. Support Care Cancer. 2024 Jul 18;32(8):523. doi: 10.1007/s00520-024-08734-6.
- Derived from this study: PubMed 37609806Badger T, Segrin C, Crane T, Morrill K, Sikorskii A. Social determinants of health, psychological distress, and caregiver burden among informal cancer caregivers of cancer survivors during treatment. J Psychosoc Oncol. 2024;42(3):333-350. doi: 10.1080/07347332.2023.2248486. Epub 2023 Aug 23.
- Individual participant dataSharing planned: Yes. The investigators will share the findings and data with other researchers, the public, and key stakeholders based on the principles that NIH has articulated regarding the sharing of study results and resources. The University of Arizona agrees that data sharing is essential for expedited translation of research results into knowledge, products, and procedures to improve health. Sharing of study results Manuscript based on results from the proposed study will be published in peer-reviewed journals. The investigators will select "open access" options for these manuscripts whenever possible. Data Sharing Data from this study will be available to other researchers under the following conditions: 1) appropriate human subjects protection is in place; 2) data have been de-identified; and 3) study investigators have publicly presented and published key findings. Data and safety monitoring plan is described under Human Subjects.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Terry Badger, PhD principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Handbook and TIP-C plus Handbook in people with Cancer, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom Severity Index- Comparison of Two Groups Created by First Randomization (time frame: Weeks 1-13 and week 17). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03743415, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.