CancerNCT05360498
Symptom Management for Rural-Urban Cancer Survivors and Caregivers
A study testing Adaptive Symptom Management and Survivorship Handbook (SMSH) and Telephone Interpersonal Counseling (TIP-C) and NCI Brochure in people with Cancer and Cancer Survivors, run by University of Arizona at 1 site in United States.
Trial summary
As the population of cancer survivors increases substantially, meeting the health care and psychosocial needs of this population has become a national priority. After treatment ends, cancer survivors still experience a range of physical and psychological symptoms that require management. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer, Cancer Survivors, Informal Caregivers
- What is being tested?
- Adaptive Symptom Management and Survivorship Handbook (SMSH) and Telephone Interpersonal Counseling (TIP-C) and NCI Brochure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 555 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Aug 2022to 12 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 18 or older
- within 4 weeks of completing or within 2 years of having completed cancer treatment with curative intent
- able to perform basic activities of daily living
- cognitively oriented to time, place, and person (recruiter determined)
- able to speak and understand English or Spanish
- access to a telephone
Show all 12Show fewer
- has a caregiver who can be any relationship role (e.g., spouse, sibling, parent, friend) who can participate with them.
- age 18 or older
- able to speak and understand English or Spanish
- telephone access
- not currently receiving counseling and/or psychotherapy
- not currently treated for cancer
Who cannot join
- Less than 18 years of age
- Diagnosis of psychotic disorder
- Nursing home resident
- Bedridden
- Currently receiving counseling and/or psychotherapy
- Less than 18 years of age
- Currently treated for cancer to preserve the distinguishability of "survivor" and "caregiver"
- Currently receiving counseling and/or psychotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Need-based Adaptive Symptom Management to Address Social Determinants of Health at Individual, Interpersonal, and Community Levels
As the population of cancer survivors increases substantially, meeting the health care and psychosocial needs of this population has become a national priority. After treatment ends, cancer survivors still experience a range of physical and psychological symptoms that require management. The post-treatment period can present new challenges for many survivors as they encounter communication gaps in the transition from oncology to primary care, leaving unmet needs for information and management of lingering symptoms. The role of informal caregivers remains important during this post-treatment period and psychosocial interventions that meet the needs (e.g., information, symptom management) of both members of the dyad are highly valuable to caregivers and survivors. Many geographic and social determinants of health care use (e.g., distance to specialty care centers, available primary care providers, and public transportation) make access to care and adherence to recommended healthcare guidelines difficult for survivors and caregivers, especially those who reside in rural areas. Rural residents with cancer and their caregivers during the post-treatment period are underrepresented in symptom management research.
To address the unmet needs (e.g., information, symptom management) of cancer survivors and their caregivers after cancer treatment, this team has developed, tested, and investigated two telephone delivered interventions for survivors and their caregivers: Symptom Management and Survivorship Handbook (SMSH) and Telephone Interpersonal Counseling (TIP-C).
Read the detailed description
This randomized control trial will be composed of at least 106 survivors that are ending their treatment or within 2 years of having completed cancer treatment with curative intent and their informal caregivers. This study will include participants of diverse backgrounds (40% Latinx) from urban and rural (approximately 50% each) areas. The dyad (survivor-caregiver) will be randomly assigned to either: 1) Symptom Management and Survivorship Guideline (Handbook) or 2) Attention control. The participants will receive weekly phone calls during 16 weeks where the interventionist will utilize the General Symptom Management Scale (GSDS) to assess their symptoms and level of symptom distress. After the initial 8 weeks in the Handbook group, the survivor's and caregiver's symptom distress will be assessed. If either the survivor or caregiver indicate elevated psychological distress for any two consecutive weeks during weeks 2 through 8, there will be an addition of TIP-C to their Handbook intervention from weeks 8 through 16. The participants in the attention control group will receive a National Cancer Institute brochure: Facing Forward: Life After Cancer Treatment plus, 16 weekly calls to assess their symptoms. Regardless of randomization, all participants will complete a baseline call and two exit interviews at weeks 17 and 24.
The specific aims are to:
- Determine if the adaptive need-based SMSH+TIP-C sequence results in improved outcomes compared to the attention control. Hypothesis 1a. SMSH+TIP-C will result in lower psychological distress and summed severity index of 14 other symptoms (primary outcomes) over weeks 1-17 and 24, more appropriately scheduled and less unscheduled health services use (secondary outcomes) over weeks 1-24 for survivors and caregivers. Hypothesis 1b. Improvements in primary and secondary outcomes will be partially mediated by 1) greater enactment of SMSH strategies in weeks 1-16 and 2) improved perceptions of social support and social isolation by week 17 for survivor and caregivers.
- Test longitudinal (weeks 1-24) dyadic interdependence in primary and secondary outcomes of survivors and caregivers to determine if there are reciprocating effects between dyad members.
- Explore if rural versus urban residence and associated Social Determinant of Health factors (e.g., ethnicity, socio-economic status [SES], age, insurance) moderate the effects of the SMSH+TIP-C intervention on primary and secondary outcomes and modify the strength of dyadic interdependence in these outcomes for survivors and caregivers.
The interventions will be delivered in English or Spanish, depending on the language preference of the participant.
- Conditions
- Cancer, Cancer Survivors, Informal Caregivers, Psychological Distress
- Being tested
- Adaptive Symptom Management and Survivorship Handbook (SMSH) and Telephone Interpersonal Counseling (TIP-C), NCI Brochure
- Keywords
- Cancer, Caregivers, Rural, Urban, Symptom Management, Psychosocial Oncology, Telephone Intervention
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptive Symptom Management and Survivorship Handbook (SMSH) and Telephone Interpersonal Counseling (TIP-C)Behavioural
This group will get weekly calls for 16 weeks and two follow-up assessments. Participants will be asked to rate their symptoms on a 0-10 scale at each call. This group will receive the SMSH, a printed evidence-based self-care management handbook with specific modules, that will be directed to use for symptoms rated 4 or higher on a 0-10 scale. For symptoms ≥7, participants will be asked to report the symptom to their provider. At each weekly call, participants will be asked: if they tried symptom self-management strategies and, if yes, which strategies were used. These calls will take 10-15 minutes. If during 8 weeks of SMSH, either the survivor or caregiver have distress (symptoms 4 or greater on a 0-10 scale) for any two consecutive weeks during weeks 2-8, TIP-C will be added for the dyad for 8 weeks. The addition of TIP-C can start between weeks 4 and 9. Dyads will continue the SMSH in addition to the TIPC. TIP-C calls will take 35-45 minutes.
NCI BrochureBehavioural
The attention control arm will receive an NCI brochure: Facing Forward: Life After Cancer Treatment. This group will also get weekly calls for 16 weeks and complete two exit interviews. The NCI brochure will not be address, the purpose of these calls will only be to record participant's symptoms throughout the study. These calls will take about 10 minutes or less.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Adaptive Need-based Sequence Receives: Behavioral: Adaptive Symptom Management and Survivorship Handbook (SMSH) and Telephone Interpersonal Counseling (TIP-C) |
| Attention control | Active comparator | This group will be participants that were randomized to the "Attention control" arm and will not receive the SMSH + TIP-C adaptive intervention. Receives: Behavioral: NCI Brochure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Number and Distressed Associated with Survivors' and Caregivers' Symptoms
Symptoms will be measured using the General Symptom Distress Scale (GSDS), which is an instrument that allows a quick assessment of symptoms. It evaluates 15 symptoms such as: depression, anxiety, pain, shortness of breath, nausea, vomiting, diarrhea, constipation, fatigue, cough, poor appetite, sleep difficulties, swelling in hands and feet, difficulty concentrating, and headaches. Participants indicate the presence of each symptom and rate their severity on a scale of 0-10; 0= not experiencing this symptom, 1=mildly distressing to 10=extremely distressing.
Measured: The GSDS will be captured at baseline, during the 16 weekly calls and during the two exit interviews at weeks 17 and 24.
Change in Depression and Anxiety of Survivors' and Caregivers'
To obtain more detail and precision in the measurement of depressive and anxiety symptoms, the PROMIS-short forms 8: depression and anxiety will be administered
Measured: The PROMIS forms will be administered at baseline and two exit interviews at weeks 17 and 24.
Secondary outcomes (2)
Change in Survivors' and Caregivers' health services use: Unscheduled and scheduled visits
Unscheduled and scheduled health visits such as: hospitalizations, urgent care and ER visits and health maintenance and survivorship health service use will be measured. Each participant will be asked to recall scheduled and unscheduled visits, their reasons, duration and where the services were received. We will ask about all preventative health services. For each service, a rating using 3 categories (recommended service was performed, not performed or partially performed, or not recommended and performed) will be made based on the current guidelines.
Measured: These service use will be measured at baseline, week 17 and week 24.
Survivors' and Caregivers' health services use: The American Society of Clinical Oncology Survivorship Guidelines
We will measure health care utilization consistent with clinical practice guidelines for patients in the 24 months after completion of cancer treatment. For example, colon cancer survivors should have a physical exam visit every three to six months, a colonoscopy one year after surgery, a computed tomography (CT) scan (if recommended), and at least four CEA tests. Our 3-category rating for use of each guideline will capture the important distinctions for different services. Extensive previous research documents self-report is a reliable and valid method to collect health services use data especially when standardized methods are used and the recall period is short (over 12 months), as in this project. Self-report is the only reasonable and cost-effective way to assess healthcare use, as it would be impossible to access health records across the multiple systems and payers.
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start22 Aug 2022
- Primary completion12 Jan 2026
- Study completion12 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 555 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Sponsor
- Investigators
- Chris Segrin, Ph.D., Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05360498
- Sponsor's protocol ID
- 35164
- Status last verified
- Jan 2026
- First submitted
- 27 Apr 2022
- Last updated
- 3 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participant data will be shared with Dr. Alla Sikorski as she is the statistician for our research team. Dr. Sikorski will perform quality assurance checks, data analysis, data management, etc. De-identified data will be transferred into SAS 9.4 for such analysis.
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Need-based Adaptive Symptom Management to Address Social Determinants of Health at Individual, Interpersonal, and Community Levels
- ClinicalTrials.gov ID
- NCT05360498
- Acronym / sponsor ID
- 35164
- Conditions
- Cancer, Cancer Survivors, Informal Caregivers, Psychological Distress
- Keywords
- Cancer, Caregivers, Rural, Urban, Symptom Management, Psychosocial Oncology, Telephone Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 555 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- 22 Aug 2022 (actual)
- Primary completion
- 12 Jan 2026 (actual)
- Study completion
- 12 Jan 2026 (actual)
- First posted
- 4 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
As the population of cancer survivors increases substantially, meeting the health care and psychosocial needs of this population has become a national priority. After treatment ends, cancer survivors still experience a range of physical and psychological symptoms that require management. The post-treatment period can present new challenges for many survivors as they encounter communication gaps in the transition from oncology to primary care, leaving unmet needs for information and management of lingering symptoms. The role of informal caregivers remains important during this post-treatment period and psychosocial interventions that meet the needs (e.g., information, symptom management) of both members of the dyad are highly valuable to caregivers and survivors. Many geographic and social determinants of health care use (e.g., distance to specialty care centers, available primary care providers, and public transportation) make access to care and adherence to recommended healthcare guidelines difficult for survivors and caregivers, especially those who reside in rural areas. Rural residents with cancer and their caregivers during the post-treatment period are underrepresented in symptom management research.
To address the unmet needs (e.g., information, symptom management) of cancer survivors and their caregivers after cancer treatment, this team has developed, tested, and investigated two telephone delivered interventions for survivors and their caregivers: Symptom Management and Survivorship Handbook (SMSH) and Telephone Interpersonal Counseling (TIP-C).
Detailed description
This randomized control trial will be composed of at least 106 survivors that are ending their treatment or within 2 years of having completed cancer treatment with curative intent and their informal caregivers. This study will include participants of diverse backgrounds (40% Latinx) from urban and rural (approximately 50% each) areas. The dyad (survivor-caregiver) will be randomly assigned to either: 1) Symptom Management and Survivorship Guideline (Handbook) or 2) Attention control. The participants will receive weekly phone calls during 16 weeks where the interventionist will utilize the General Symptom Management Scale (GSDS) to assess their symptoms and level of symptom distress. After the initial 8 weeks in the Handbook group, the survivor's and caregiver's symptom distress will be assessed. If either the survivor or caregiver indicate elevated psychological distress for any two consecutive weeks during weeks 2 through 8, there will be an addition of TIP-C to their Handbook intervention from weeks 8 through 16. The participants in the attention control group will receive a National Cancer Institute brochure: Facing Forward: Life After Cancer Treatment plus, 16 weekly calls to assess their symptoms. Regardless of randomization, all participants will complete a baseline call and two exit interviews at weeks 17 and 24.
The specific aims are to:
- Determine if the adaptive need-based SMSH+TIP-C sequence results in improved outcomes compared to the attention control. Hypothesis 1a. SMSH+TIP-C will result in lower psychological distress and summed severity index of 14 other symptoms (primary outcomes) over weeks 1-17 and 24, more appropriately scheduled and less unscheduled health services use (secondary outcomes) over weeks 1-24 for survivors and caregivers. Hypothesis 1b. Improvements in primary and secondary outcomes will be partially mediated by 1) greater enactment of SMSH strategies in weeks 1-16 and 2) improved perceptions of social support and social isolation by week 17 for survivor and caregivers.
- Test longitudinal (weeks 1-24) dyadic interdependence in primary and secondary outcomes of survivors and caregivers to determine if there are reciprocating effects between dyad members.
- Explore if rural versus urban residence and associated Social Determinant of Health factors (e.g., ethnicity, socio-economic status [SES], age, insurance) moderate the effects of the SMSH+TIP-C intervention on primary and secondary outcomes and modify the strength of dyadic interdependence in these outcomes for survivors and caregivers.
The interventions will be delivered in English or Spanish, depending on the language preference of the participant.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: Adaptive Symptom Management and Survivorship Handbook (SMSH) and Telephone Interpersonal Counseling (TIP-C)Adaptive Need-based Sequence |
| Attention control | Active comparator | Behavioral: NCI BrochureThis group will be participants that were randomized to the "Attention control" arm and will not receive the SMSH + TIP-C adaptive intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- age 18 or older
- within 4 weeks of completing or within 2 years of having completed cancer treatment with curative intent
- able to perform basic activities of daily living
- cognitively oriented to time, place, and person (recruiter determined)
- able to speak and understand English or Spanish
Key exclusion criteria (8 listed)
- Less than 18 years of age
- Diagnosis of psychotic disorder
- Nursing home resident
- Bedridden
- 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 |
|---|---|---|
| Adaptive Symptom Management and Survivorship Handbook (SMSH) and Telephone Interpersonal Counseling (TIP-C)This group will get weekly calls for 16 weeks and two follow-up assessments. Participants will be asked to rate their symptoms on a 0-10 scale at each call. This group will receive the SMSH, a printed evidence-based self-care management handbook with specific modules, that will be directed to use for symptoms rated 4 or higher on a 0-10 scale. For symptoms ≥7, participants will be asked to report the symptom to their provider. At each weekly call, participants will be asked: if they tried symptom self-management strategies and, if yes, which strategies were used. These calls will take 10-15 minutes. If during 8 weeks of SMSH, either the survivor or caregiver have distress (symptoms 4 or greater on a 0-10 scale) for any two consecutive weeks during weeks 2-8, TIP-C will be added for the dyad for 8 weeks. The addition of TIP-C can start between weeks 4 and 9. Dyads will continue the SMSH in addition to the TIPC. TIP-C calls will take 35-45 minutes. | Behavioural | Intervention Arm |
| NCI BrochureThe attention control arm will receive an NCI brochure: Facing Forward: Life After Cancer Treatment. This group will also get weekly calls for 16 weeks and complete two exit interviews. The NCI brochure will not be address, the purpose of these calls will only be to record participant's symptoms throughout the study. These calls will take about 10 minutes or less. | Behavioural | Attention control |
Primary outcome
Change in Number and Distressed Associated with Survivors' and Caregivers' Symptoms
Time frame: The GSDS will be captured at baseline, during the 16 weekly calls and during the two exit interviews at weeks 17 and 24.
Symptoms will be measured using the General Symptom Distress Scale (GSDS), which is an instrument that allows a quick assessment of symptoms. It evaluates 15 symptoms such as: depression, anxiety, pain, shortness of breath, nausea, vomiting, diarrhea, constipation, fatigue, cough, poor appetite, sleep difficulties, swelling in hands and feet, difficulty concentrating, and headaches. Participants indicate the presence of each symptom and rate their severity on a scale of 0-10; 0= not experiencing this symptom, 1=mildly distressing to 10=extremely distressing.
Change in Depression and Anxiety of Survivors' and Caregivers'
Time frame: The PROMIS forms will be administered at baseline and two exit interviews at weeks 17 and 24.
To obtain more detail and precision in the measurement of depressive and anxiety symptoms, the PROMIS-short forms 8: depression and anxiety will be administered
2 secondary outcomes
Change in Survivors' and Caregivers' health services use: Unscheduled and scheduled visits
Time frame: These service use will be measured at baseline, week 17 and week 24.
Survivors' and Caregivers' health services use: The American Society of Clinical Oncology Survivorship Guidelines
Time frame: Week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Individual participant dataSharing planned: Yes. Participant data will be shared with Dr. Alla Sikorski as she is the statistician for our research team. Dr. Sikorski will perform quality assurance checks, data analysis, data management, etc. De-identified data will be transferred into SAS 9.4 for such analysis.
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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.
Chris Segrin, Ph.D. 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 Adaptive Symptom Management and Survivorship Handbook (SMSH) and Telephone Interpersonal Counseling (TIP-C) and NCI Brochure in people with Cancer and Cancer Survivors, 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 12 inclusion and 8 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 3 Feb 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Number and Distressed Associated with Survivors' and Caregivers' Symptoms (time frame: The GSDS will be captured at baseline, during the 16 weekly calls and during the two exit interviews at weeks 17 and 24.). 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?
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 3 Feb 2026.