Cancer MetastaticSMSH and SMSH+NCT07415564
Symptom Management and Survivorship Plus Coaching for Advanced Cancer Survivors and Their Caregivers
A study testing Symptom Management and Survivorship Handbook + Coaching and Symptom Management and Survivorship Handbook in people with Cancer Metastatic and Symptoms and Signs, run by University of Arizona at 1 site in United States.
Trial summary
The protocol will include a 10-week Symptom Management and Survivorship Handbook (SMSH) intervention to address informational needs for the management of physical and psychological symptoms, bundled with telephone delivered health coaching to address their symptom interference with physical, psychological and social… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Metastatic, Symptoms and Signs, Quality of Life
- What is being tested?
- Symptom Management and Survivorship Handbook + Coaching and Symptom Management and Survivorship Handbook
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 6 May 2026to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age 18 or older
- Diagnosed with metastatic or stage IV breast, gastrointestinal (GI), and melanoma cancer
- 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 11Show fewer
- Has a caregiver in any relationship role (e.g., spouse, sibling, parent, friend) who can.
- Age 18 or older
- Able to speak and understand English or Spanish
- Telephone access
- Not currently treated for cancer
Who cannot join
- Nursing home resident
- Bedridden
- Hospice care
- Currently receiving a symptom management intervention
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Arizona Cancer Center
Tucson, Arizona, 85719
Michele Chu-Pilli, MS, 520-626-1183, chum@arizona.edu
About this study
Official title: Symptom Management and Survivorship Plus Coaching to Reduce Symptom Severity and Improve Health Related-quality of Life (HR-QOL) for Breast, GI and Melanoma Cancer Survivors and Their Caregivers
The protocol will include a 10-week Symptom Management and Survivorship Handbook (SMSH) intervention to address informational needs for the management of physical and psychological symptoms, bundled with telephone delivered health coaching to address their symptom interference with physical, psychological and social functioning. The SMSH intervention, which includes both symptom assessment and management, is simple to implement, scalable, and evidence-based will be delivered to all survivors and caregivers (dyads) in this study, and will serve as an active control. In addition to the SMSH, intervention arm dyads will receive health coaching to address symptom interference and reduce social isolation. Symptom burden is more pronounced in marginalized populations such as Latina/o, rural, older age survivors and their caregivers.18-20 Many health disparities in these populations are underwritten by social isolation due to lack of access, disconnection from linguistically competent health care, mobility, and geographic proximity,21-23 and health coaching can address these issues.
The specific aims of the proposed feasibility study are to determine among survivors with metastatic or stage IV cancer and their caregivers (dyads):
Read more
Aim 1: Demonstrate SMSH plus health coaching feasibility (recruitment, retention, satisfaction (acceptability and appropriateness) for cancer survivors and their caregivers. Benchmarks: Recruitment 70% approached, Retention 75%, and participant satisfaction through qualitative exit interviews in week 11.
Aim 2: Collect preliminary data for the intervention impact on whether the SMSH + health coaching results in lowered burden of 24 symptoms (primary outcome) over weeks 1-10, and improved HRQoL (social, physical, psychological) (secondary outcome) at week 11, compared to SMSH alone.
Aim 3. Examine the enactment of self-management strategies in SMSH+health coaching versus SMSH alone.
The proposed pilot trial will provide proof of concept for the SMSH coupled with a live telephone delivered health coaching intervention to improve symptom management and HRQoL for metastatic breast, GI, and melanoma cancer survivors and caregivers. By addressing physical and psychological symptoms and survivorship using scalable, accessible interventions delivered via telephone, within reach of traditionally underserved populations, the findings have the potential to lay the foundation for the dissemination and implementation of a practical solution to meet survivor-caregiver needs both locally and nationally.
- Conditions
- Cancer Metastatic, Symptoms and Signs, Quality of Life
- Being tested
- Symptom Management and Survivorship Handbook + Coaching, Symptom Management and Survivorship Handbook
- Keywords
- cancer, Metastatic cancer, Symptom management, Cancer survivorship, Cancer caregivers
- Medical subject headings
- Neoplasm Metastasis, Signs and Symptoms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symptom Management and Survivorship Handbook + CoachingBehavioural
Also called SMSH+
Coaches call survivors and caregivers separately each week. In week one, they introduce themselves and the intervention, explain the 10-call structure, and help participants prioritize symptoms and set management goals. Coaches review SMSH recommendations, coach on symptom management strategies, and use techniques such as motivational interviewing and self-monitoring. Coaches remind participants that some strategies help multiple symptoms, and recommend talking to a provider if any symptom scores above 3. In sessions 2-10, coaches check in, administer a symptom questionnaire, review prior goals, and document progress, barriers, and new goals. Each session covers discovery, desired outcome, pathways, context, and design.
Symptom Management and Survivorship HandbookBehavioural
Also called SMSH alone
Survivors and caregivers receive a printed Symptom Management and Survivorship Handbook (SMSH), proven to help manage symptoms. The SMSH covers 24 common cancer symptoms (like fatigue, depression, sleep issues, pain), plus lifestyle, behavior, and survivorship guidelines. For 10 weeks, an interventionist calls weekly to assess symptoms and refer to relevant handbook chapters.
| Study group | Role | What they receive |
|---|---|---|
| Symptom Management and Survivorship Handbook (SMSH) | Active comparator | Survivors and caregivers are mailed a printed Symptom Management and Survivorship Handbook (SMSH or Handbook), which has been shown to help survivors and caregivers manage symptoms in other studies. The SMSH includes a chapter for 24 common cancer symptoms (e.g., fatigue, depression, anxiety, sleep difficulties, pain, etc.) and provides tips and strategies to help with symptom management. The SMSH also includes lifestyle and behavior tips, survivorship guidelines, and surveillance guidelines. Survivors and caregivers are called by an interventionist via telephone once a week for 10 weeks to assess symptoms and make referrals to chapters in the handbook based on their reports. Receives: Behavioral: Symptom Management and Survivorship Handbook |
| Symptom Management and Survivorship Handbook + Coaching | Experimental | Survivors and caregivers are mailed the printed Symptom Management and Survivorship Handbook (SMSH or Handbook), which has been shown to help them manage symptoms in other studies. The SMSH includes a chapter for 24 common cancer symptoms (e.g., fatigue, depression, anxiety, sleep difficulties, pain, etc.) and provides tips and strategies to help with symptom management. The SMSH also includes lifestyle and behavior tips, survivorship guidelines, and surveillance guidelines. Trained health coaches will call the survivor and caregiver separately each week for 10 weeks to assess symptoms, make referrals to SMSH, and use behavioral theory techniques to facilitate goal setting and symptom self-management. Receives: Behavioral: Symptom Management and Survivorship Handbook + Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom severity
Assess whether SMSH combined with health coaching reduces the burden of 24 symptoms over 10 weeks compared to SMSH alone. Symptom burden will be measured using summary severity and interference scores from the Patient-Reported Outcome Common Terminology Criteria for Adverse Events (PRO-CTCAE). Severity is rated on a scale of 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe. Interference is rated on a scale of 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much. Frequency is rated as 0=never, 1=rarely, 2=occasionally, 3=frequently, 4=almost constantly. As outlined in the PRO-CTCAE, frequency, severity, and interference questions will be asked for each item available. If frequency is "never," severity and interference will not be asked. Summary scores for severity and interference will be derived from the toxicity index (TI) developed by Rogatko et al. for CTCAE grades and applied to the PRO-CTCAE scores over weeks 1-8. Higher scores indicate worse outcomes.
Measured: 10 weeks
Secondary outcomes (1)
Health Related Quality of Life (HRQoL)
Determine whether SMSH combined with health coaching improves HRQoL (social, physical, psychological) at week 11 compared to SMSH alone. HRQoL will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Profile-43, which is suitable for both survivors and caregivers and is available in English and Spanish. PROMIS domains include depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and satisfaction with participation in social roles. Each item uses a 5-point Likert scale (1-5) plus a single pain intensity rating (0-10 for direct pain assessment). The scores for each domain are not summed into a single score and are meant to be used together to reflect HRQoL domains. A T-score of 50 represents the U.S. general population average, with a standard deviation of 10. Higher scores indicate worse outcomes for symptoms/interference, but better outcomes for physical function.
Measured: 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start6 May 2026
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer MetastaticStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Terry Badger, University of Arizona
- Investigators
- Terry A Badger, RN, PhD, Principal investigator, University of Arizona College of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07415564
- Sponsor's protocol ID
- STUDY00007379
- Acronym
- SMSH and SMSH+
- Status last verified
- Jul 2026
- First submitted
- 29 Jan 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptom Management and Survivorship Plus Coaching to Reduce Symptom Severity and Improve Health Related-quality of Life (HR-QOL) for Breast, GI and Melanoma Cancer Survivors and Their Caregivers
- ClinicalTrials.gov ID
- NCT07415564
- Acronym / sponsor ID
- SMSH and SMSH+ / STUDY00007379
- Conditions
- Cancer Metastatic, Symptoms and Signs, Quality of Life
- Keywords
- cancer, Metastatic cancer, Symptom management, Cancer survivorship, Cancer caregivers
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 6 May 2026 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 17 Feb 2026 (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.
The protocol will include a 10-week Symptom Management and Survivorship Handbook (SMSH) intervention to address informational needs for the management of physical and psychological symptoms, bundled with telephone delivered health coaching to address their symptom interference with physical, psychological and social functioning. The SMSH intervention, which includes both symptom assessment and management, is simple to implement, scalable, and evidence-based will be delivered to all survivors and caregivers (dyads) in this study, and will serve as an active control. In addition to the SMSH, intervention arm dyads will receive health coaching to address symptom interference and reduce social isolation. Symptom burden is more pronounced in marginalized populations such as Latina/o, rural, older age survivors and their caregivers.18-20 Many health disparities in these populations are underwritten by social isolation due to lack of access, disconnection from linguistically competent health care, mobility, and geographic proximity,21-23 and health coaching can address these issues.
The specific aims of the proposed feasibility study are to determine among survivors with metastatic or stage IV cancer and their caregivers (dyads):
Aim 1: Demonstrate SMSH plus health coaching feasibility (recruitment, retention, satisfaction (acceptability and appropriateness) for cancer survivors and their caregivers. Benchmarks: Recruitment 70% approached, Retention 75%, and participant satisfaction through qualitative exit interviews in week 11.
Aim 2: Collect preliminary data for the intervention impact on whether the SMSH + health coaching results in lowered burden of 24 symptoms (primary outcome) over weeks 1-10, and improved HRQoL (social, physical, psychological) (secondary outcome) at week 11, compared to SMSH alone.
Aim 3. Examine the enactment of self-management strategies in SMSH+health coaching versus SMSH alone.
The proposed pilot trial will provide proof of concept for the SMSH coupled with a live telephone delivered health coaching intervention to improve symptom management and HRQoL for metastatic breast, GI, and melanoma cancer survivors and caregivers. By addressing physical and psychological symptoms and survivorship using scalable, accessible interventions delivered via telephone, within reach of traditionally underserved populations, the findings have the potential to lay the foundation for the dissemination and implementation of a practical solution to meet survivor-caregiver needs both locally and nationally.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Symptom Management and Survivorship Handbook (SMSH) | Active comparator | Behavioral: Symptom Management and Survivorship HandbookSurvivors and caregivers are mailed a printed Symptom Management and Survivorship Handbook (SMSH or Handbook), which has been shown to help survivors and caregivers manage symptoms in other studies. The SMSH includes a chapter for 24 common cancer symptoms (e.g., fatigue, depression, anxiety, sleep difficulties, pain, etc.) and provides tips and strategies to help with symptom management. The SMSH also includes lifestyle and behavior tips, survivorship guidelines, and surveillance guidelines. Survivors and caregivers are called by an interventionist via telephone once a week for 10 weeks to assess symptoms and make referrals to chapters in the handbook based on their reports. |
| Symptom Management and Survivorship Handbook + Coaching | Experimental | Behavioral: Symptom Management and Survivorship Handbook + CoachingSurvivors and caregivers are mailed the printed Symptom Management and Survivorship Handbook (SMSH or Handbook), which has been shown to help them manage symptoms in other studies. The SMSH includes a chapter for 24 common cancer symptoms (e.g., fatigue, depression, anxiety, sleep difficulties, pain, etc.) and provides tips and strategies to help with symptom management. The SMSH also includes lifestyle and behavior tips, survivorship guidelines, and surveillance guidelines. Trained health coaches will call the survivor and caregiver separately each week for 10 weeks to assess symptoms, make referrals to SMSH, and use behavioral theory techniques to facilitate goal setting and symptom self-management. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 18 or older
- Diagnosed with metastatic or stage IV breast, gastrointestinal (GI), and melanoma cancer
- 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 (4 listed)
- Nursing home resident
- Bedridden
- Hospice care
- Currently receiving a symptom management intervention
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 |
|---|---|---|
| Symptom Management and Survivorship Handbook + CoachingAlso: SMSH+Coaches call survivors and caregivers separately each week. In week one, they introduce themselves and the intervention, explain the 10-call structure, and help participants prioritize symptoms and set management goals. Coaches review SMSH recommendations, coach on symptom management strategies, and use techniques such as motivational interviewing and self-monitoring. Coaches remind participants that some strategies help multiple symptoms, and recommend talking to a provider if any symptom scores above 3. In sessions 2-10, coaches check in, administer a symptom questionnaire, review prior goals, and document progress, barriers, and new goals. Each session covers discovery, desired outcome, pathways, context, and design. | Behavioural | Symptom Management and Survivorship Handbook + Coaching |
| Symptom Management and Survivorship HandbookAlso: SMSH aloneSurvivors and caregivers receive a printed Symptom Management and Survivorship Handbook (SMSH), proven to help manage symptoms. The SMSH covers 24 common cancer symptoms (like fatigue, depression, sleep issues, pain), plus lifestyle, behavior, and survivorship guidelines. For 10 weeks, an interventionist calls weekly to assess symptoms and refer to relevant handbook chapters. | Behavioural | Symptom Management and Survivorship Handbook (SMSH) |
Primary outcome
Symptom severity
Time frame: 10 weeks
Assess whether SMSH combined with health coaching reduces the burden of 24 symptoms over 10 weeks compared to SMSH alone. Symptom burden will be measured using summary severity and interference scores from the Patient-Reported Outcome Common Terminology Criteria for Adverse Events (PRO-CTCAE). Severity is rated on a scale of 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe. Interference is rated on a scale of 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much. Frequency is rated as 0=never, 1=rarely, 2=occasionally, 3=frequently, 4=almost constantly. As outlined in the PRO-CTCAE, frequency, severity, and interference questions will be asked for each item available. If frequency is "never," severity and interference will not be asked. Summary scores for severity and interference will be derived from the toxicity index (TI) developed by Rogatko et al. for CTCAE grades and applied to the PRO-CTCAE scores over weeks 1-8. Higher scores indicate worse outcomes.
1 secondary outcome
Health Related Quality of Life (HRQoL)
Time frame: 11 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Terry A Badger, RN, PhD principal investigator
University of Arizona College of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Symptom Management and Survivorship Handbook + Coaching and Symptom Management and Survivorship Handbook in people with Cancer Metastatic and Symptoms and Signs, 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 11 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 20 Jul 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Molly Hadeed, MPA, MSPH (520-626-0583, mcbarry@arizona.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom severity (time frame: 10 weeks). 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 20 Jul 2026.