Psychosocial DistressNCT07673731
Addressing Cancer-Related Distress Through Survivorship Care in Community Oncology
A study testing Structured Survivorship Visit in people with Psychosocial Distress and Cancer, run by Ellis Medicine at 1 site in United States.
Trial summary
The goal of this study is to understand whether providing a structured survivorship care visit at the beginning of cancer treatment is associated with changes in distress and quality of life in adults with cancer receiving treatment in a community oncology clinic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychosocial Distress, Cancer
- What is being tested?
- Structured Survivorship Visit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2026to Jun 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
- Patients must fulfill all the following criteria to be included in the study:
- Age 18 years and older.
- Patients with histologically confirmed malignancy, any stage or type.
- Beginning active therapy (either in oral or IV) for cancer at Ellis Medicine/Roswell Park Medical Oncology.
- A score of ≥4 on the NCCN Distress Thermometer at screening.
- Able and willing to provide written informed consent.
- Ability to read and understand English sufficiently to complete study questionnaires.
Who cannot join
- Patients with one or more of the following criteria will be excluded from the study:
- Under the age of 18 years.
- Patient is unable to provide informed consent.
- Currently receiving ongoing therapy or have had treatment for cancer in the past (i.e., not a new start)
- Significant cognitive impairment that would preclude completion of study questionnaires
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
Ellis Medicine/Roswell Park Medical Oncology
Schenectady, New York, 12308
About this study
The goal of this study is to understand whether providing a structured survivorship care visit at the beginning of cancer treatment is associated with changes in distress and quality of life in adults with cancer receiving treatment in a community oncology clinic. The main questions it aims to answer are:
- Is participation in a structured survivorship visit at the start of active treatment associated with changes in psychological distress?
- Is participation in the survivorship visit associated with changes in quality of life?
Read more
Participants will:
- Be asked to complete questionnaires about their level of distress and overall quality of life.
- Participate in a single survivorship visit with the clinic's Physician Assistant at the Ellis Medical Oncology Clinic.
- Complete the same questionnaires again approximately two weeks and one month after the survivorship visit.
Read the detailed description
Psychological distress is common among individuals with cancer, and many patients experience emotional, social, physical, and practical challenges throughout treatment. Despite the high prevalence of distress, psychosocial needs often go unrecognized or inadequately addressed in routine oncology care. Unmet psychosocial needs have been associated with poorer quality of life, increased symptom burden, and difficulties coping with cancer and its treatment.
Survivorship care may represent one approach to addressing these needs. Cancer survivorship care focuses on the ongoing physical, emotional, and psychosocial effects of cancer and is designed to promote overall well-being and quality of life. Traditionally, survivorship care has been delivered after completion of active treatment. However, active treatment is often one of the most physically and emotionally demanding phases of the cancer journey. Providing survivorship care earlier may allow concerns to be identified and addressed as they arise rather than waiting until treatment has ended.
This single-arm pilot study aims to evaluate the feasibility and preliminary impact of a structured survivorship visit for patients experiencing clinically significant distress in a community oncology clinic. Patients with a score of ≥4 on the NCCN Distress Thermometer who express interest in participating will be offered a survivorship visit guided by their Distress Thermometer and Problem List responses. 15 adult patients will participate in this pilot. Changes in psychological distress and quality of life will be assessed using the NCCN Distress Thermometer and the Functional Assessment of Cancer Therapy-General (FACT-G) before and after the survivorship visit to explore whether this brief, structured intervention may be associated with improvements in distress and quality of life. Findings from this study will help inform the development of future studies evaluating the role of early survivorship care in improving psychosocial outcomes and quality of life among patients with cancer.
- Conditions
- Psychosocial Distress, Cancer
- Being tested
- Structured Survivorship Visit
- Keywords
- Cancer Survivorship, Quality of Life, Behavioral Oncology, Psychosocial Oncology, Distress, Survivorship Care, Patient-Reported Outcomes, Supportive Care
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Survivorship VisitBehavioural
A structured survivorship care visit conducted by a trained Physician Assistant during the beginning of active cancer treatment. The visit uses patient-reported distress screening results to guide discussion of psychosocial, physical, practical, and supportive care needs. Counseling, education, care coordination, and referrals may be provided as appropriate within routine clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Survivorship Visit Intervention | Experimental | Participants will receive a single structured survivorship visit during active cancer treatment. The visit will be guided by responses to the NCCN Distress Thermometer and Problem List and will address physical, emotional, social, practical, and spiritual concerns identified during distress screening. Receives: Behavioral: Structured Survivorship Visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Psychological Distress as Measured by the NCCN Distress Thermometer and Problem List
Psychological distress will be measured using the National Comprehensive Cancer Network (NCCN) Distress Thermometer and Problem List, a validated self-report measure in which participants rate their overall distress on a scale from 0 (no distress) to 10 (extreme distress). Change in distress scores from baseline to follow-up assessments will be evaluated.
Measured: Baseline, 2 weeks after survivorship visit, and 1 month after survivorship visit
Secondary outcomes (1)
Change in Quality of Life as Measured by the Functional Assessment of Cancer Therapy-General (FACT-G)
Quality of life will be assessed using the FACT-G, a 27 item validated measure of cancer-related quality of life. Total scores range from 0 to 108, with higher scores indicating better quality of life. Change in FACT-G total scores from baseline to follow-up assessments will be evaluated.
Measured: Baseline, 2 weeks after survivorship visit, and 1 month after survivorship visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Psychosocial DistressStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ellis Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.Tallat Mahmood,MD, Ellis Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07673731
- Sponsor's protocol ID
- 00008111-04302026-MAH
- Status last verified
- Jun 2026
- First submitted
- 23 Jun 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yusufov M, Adeyemi O, Flannery M, Bouillon-Minois JB, Van Allen K, Cuthel AM, Goldfeld KS, Ouchi K, Grudzen CR. Psychometric Properties of the Functional Assessment of Cancer Therapy-General for Evaluating Quality of Life in Patients With Life-Limiting Illness in the Emergency Department. J Palliat Med. 2024 Jan;27(1):63-74. doi: 10.1089/jpm.2022.0270. Epub 2023 Sep 6.
PubMed 37672598Temel JS, Greer JA, Muzikansky A, Gallagher ER, Admane S, Jackson VA, Dahlin CM, Blinderman CD, Jacobsen J, Pirl WF, Billings JA, Lynch TJ. Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med. 2010 Aug 19;363(8):733-42. doi: 10.1056/NEJMoa1000678.
PubMed 20818875Penedo FJ, Natori A, Fleszar-Pavlovic SE, Sookdeo VD, MacIntyre J, Medina H, Moreno PI, Crane TE, Moskowitz C, Calfa CL, Schlumbrecht M. Factors Associated With Unmet Supportive Care Needs and Emergency Department Visits and Hospitalizations in Ambulatory Oncology. JAMA Netw Open. 2023 Jun 1;6(6):e2319352. doi: 10.1001/jamanetworkopen.2023.19352.
PubMed 37342038Ownby KK. Use of the Distress Thermometer in Clinical Practice. J Adv Pract Oncol. 2019 Mar;10(2):175-179. Epub 2019 Mar 1.
PubMed 31538028Mollica MA, Doose M, Reed C, Tonorezos E. Defining concepts in cancer survivorship. Cancer. 2025 Aug 15;131(16):e70039. doi: 10.1002/cncr.70039.
PubMed 40810248Mehari WD, Sun Y, Lei Y, Shine S, Seyoum E, Getu MA. Unmet supportive care need and associated factors among cancer patients. BMC Cancer. 2025 Aug 2;25(1):1260. doi: 10.1186/s12885-025-14607-w.
PubMed 40753208Hong YR, Yadav S, Suk R, Khanijahani A, Erim D, Turner K. Patient-provider discussion about emotional and social needs, mental health outcomes, and benefit finding among U.S. Adults living with cancer. Cancer Med. 2021 Jun;10(11):3622-3634. doi: 10.1002/cam4.3918. Epub 2021 May 7.
PubMed 33960716Halpern MT, Viswanathan M, Evans TS, Birken SA, Basch E, Mayer DK. Models of Cancer Survivorship Care: Overview and Summary of Current Evidence. J Oncol Pract. 2015 Jan;11(1):e19-27. doi: 10.1200/JOP.2014.001403. Epub 2014 Sep 9.
PubMed 25205779Carlson LE, Zelinski EL, Toivonen KI, Sundstrom L, Jobin CT, Damaskos P, Zebrack B. Prevalence of psychosocial distress in cancer patients across 55 North American cancer centers. J Psychosoc Oncol. 2019 Jan-Feb;37(1):5-21. doi: 10.1080/07347332.2018.1521490. Epub 2018 Dec 28.
PubMed 30592249Bakitas M, Lyons KD, Hegel MT, Balan S, Brokaw FC, Seville J, Hull JG, Li Z, Tosteson TD, Byock IR, Ahles TA. Effects of a palliative care intervention on clinical outcomes in patients with advanced cancer: the Project ENABLE II randomized controlled trial. JAMA. 2009 Aug 19;302(7):741-9. doi: 10.1001/jama.2009.1198.
PubMed 19690306
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Cancer-Related Distress Through Survivorship Care in Community Oncology
- ClinicalTrials.gov ID
- NCT07673731
- Acronym / sponsor ID
- 00008111-04302026-MAH
- Conditions
- Psychosocial Distress, Cancer
- Keywords
- Cancer Survivorship, Quality of Life, Behavioral Oncology, Psychosocial Oncology, Distress, Survivorship Care, Patient-Reported Outcomes, Supportive Care
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Ellis MedicineUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 29 Jun 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 goal of this study is to understand whether providing a structured survivorship care visit at the beginning of cancer treatment is associated with changes in distress and quality of life in adults with cancer receiving treatment in a community oncology clinic. The main questions it aims to answer are:
- Is participation in a structured survivorship visit at the start of active treatment associated with changes in psychological distress?
- Is participation in the survivorship visit associated with changes in quality of life?
Participants will:
- Be asked to complete questionnaires about their level of distress and overall quality of life.
- Participate in a single survivorship visit with the clinic's Physician Assistant at the Ellis Medical Oncology Clinic.
- Complete the same questionnaires again approximately two weeks and one month after the survivorship visit.
Detailed description
Psychological distress is common among individuals with cancer, and many patients experience emotional, social, physical, and practical challenges throughout treatment. Despite the high prevalence of distress, psychosocial needs often go unrecognized or inadequately addressed in routine oncology care. Unmet psychosocial needs have been associated with poorer quality of life, increased symptom burden, and difficulties coping with cancer and its treatment.
Survivorship care may represent one approach to addressing these needs. Cancer survivorship care focuses on the ongoing physical, emotional, and psychosocial effects of cancer and is designed to promote overall well-being and quality of life. Traditionally, survivorship care has been delivered after completion of active treatment. However, active treatment is often one of the most physically and emotionally demanding phases of the cancer journey. Providing survivorship care earlier may allow concerns to be identified and addressed as they arise rather than waiting until treatment has ended.
This single-arm pilot study aims to evaluate the feasibility and preliminary impact of a structured survivorship visit for patients experiencing clinically significant distress in a community oncology clinic. Patients with a score of ≥4 on the NCCN Distress Thermometer who express interest in participating will be offered a survivorship visit guided by their Distress Thermometer and Problem List responses. 15 adult patients will participate in this pilot. Changes in psychological distress and quality of life will be assessed using the NCCN Distress Thermometer and the Functional Assessment of Cancer Therapy-General (FACT-G) before and after the survivorship visit to explore whether this brief, structured intervention may be associated with improvements in distress and quality of life. Findings from this study will help inform the development of future studies evaluating the role of early survivorship care in improving psychosocial outcomes and quality of life among patients with cancer.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Survivorship Visit Intervention | Experimental | Behavioral: Structured Survivorship VisitParticipants will receive a single structured survivorship visit during active cancer treatment. The visit will be guided by responses to the NCCN Distress Thermometer and Problem List and will address physical, emotional, social, practical, and spiritual concerns identified during distress screening. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 years and older.
- Patients with histologically confirmed malignancy, any stage or type.
- Beginning active therapy (either in oral or IV) for cancer at Ellis Medicine/Roswell Park Medical Oncology.
- A score of ≥4 on the NCCN Distress Thermometer at screening.
- Able and willing to provide written informed consent.
Key exclusion criteria (5 listed)
- Under the age of 18 years.
- Patient is unable to provide informed consent.
- Currently receiving ongoing therapy or have had treatment for cancer in the past (i.e., not a new start)
- Significant cognitive impairment that would preclude completion of study questionnaires
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 |
|---|---|---|
| Structured Survivorship VisitA structured survivorship care visit conducted by a trained Physician Assistant during the beginning of active cancer treatment. The visit uses patient-reported distress screening results to guide discussion of psychosocial, physical, practical, and supportive care needs. Counseling, education, care coordination, and referrals may be provided as appropriate within routine clinical practice. | Behavioural | Survivorship Visit Intervention |
Primary outcome
Change in Psychological Distress as Measured by the NCCN Distress Thermometer and Problem List
Time frame: Baseline, 2 weeks after survivorship visit, and 1 month after survivorship visit
Psychological distress will be measured using the National Comprehensive Cancer Network (NCCN) Distress Thermometer and Problem List, a validated self-report measure in which participants rate their overall distress on a scale from 0 (no distress) to 10 (extreme distress). Change in distress scores from baseline to follow-up assessments will be evaluated.
1 secondary outcome
Change in Quality of Life as Measured by the Functional Assessment of Cancer Therapy-General (FACT-G)
Time frame: Baseline, 2 weeks after survivorship visit, and 1 month after survivorship visit
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 29 Jun 2026.
- Background: PubMed 37672598Yusufov M, Adeyemi O, Flannery M, Bouillon-Minois JB, Van Allen K, Cuthel AM, Goldfeld KS, Ouchi K, Grudzen CR. Psychometric Properties of the Functional Assessment of Cancer Therapy-General for Evaluating Quality of Life in Patients With Life-Limiting Illness in the Emergency Department. J Palliat Med. 2024 Jan;27(1):63-74. doi: 10.1089/jpm.2022.0270. Epub 2023 Sep 6.
- Background: PubMed 20818875Temel JS, Greer JA, Muzikansky A, Gallagher ER, Admane S, Jackson VA, Dahlin CM, Blinderman CD, Jacobsen J, Pirl WF, Billings JA, Lynch TJ. Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med. 2010 Aug 19;363(8):733-42. doi: 10.1056/NEJMoa1000678.
- Background: PubMed 37342038Penedo FJ, Natori A, Fleszar-Pavlovic SE, Sookdeo VD, MacIntyre J, Medina H, Moreno PI, Crane TE, Moskowitz C, Calfa CL, Schlumbrecht M. Factors Associated With Unmet Supportive Care Needs and Emergency Department Visits and Hospitalizations in Ambulatory Oncology. JAMA Netw Open. 2023 Jun 1;6(6):e2319352. doi: 10.1001/jamanetworkopen.2023.19352.
- Background: PubMed 31538028Ownby KK. Use of the Distress Thermometer in Clinical Practice. J Adv Pract Oncol. 2019 Mar;10(2):175-179. Epub 2019 Mar 1.
- Background: PubMed 40810248Mollica MA, Doose M, Reed C, Tonorezos E. Defining concepts in cancer survivorship. Cancer. 2025 Aug 15;131(16):e70039. doi: 10.1002/cncr.70039.
- Background: PubMed 40753208Mehari WD, Sun Y, Lei Y, Shine S, Seyoum E, Getu MA. Unmet supportive care need and associated factors among cancer patients. BMC Cancer. 2025 Aug 2;25(1):1260. doi: 10.1186/s12885-025-14607-w.
- Background: PubMed 33960716Hong YR, Yadav S, Suk R, Khanijahani A, Erim D, Turner K. Patient-provider discussion about emotional and social needs, mental health outcomes, and benefit finding among U.S. Adults living with cancer. Cancer Med. 2021 Jun;10(11):3622-3634. doi: 10.1002/cam4.3918. Epub 2021 May 7.
- Background: PubMed 25205779Halpern MT, Viswanathan M, Evans TS, Birken SA, Basch E, Mayer DK. Models of Cancer Survivorship Care: Overview and Summary of Current Evidence. J Oncol Pract. 2015 Jan;11(1):e19-27. doi: 10.1200/JOP.2014.001403. Epub 2014 Sep 9.
- Background: PubMed 30592249Carlson LE, Zelinski EL, Toivonen KI, Sundstrom L, Jobin CT, Damaskos P, Zebrack B. Prevalence of psychosocial distress in cancer patients across 55 North American cancer centers. J Psychosoc Oncol. 2019 Jan-Feb;37(1):5-21. doi: 10.1080/07347332.2018.1521490. Epub 2018 Dec 28.
- Background: PubMed 19690306Bakitas M, Lyons KD, Hegel MT, Balan S, Brokaw FC, Seville J, Hull JG, Li Z, Tosteson TD, Byock IR, Ahles TA. Effects of a palliative care intervention on clinical outcomes in patients with advanced cancer: the Project ENABLE II randomized controlled trial. JAMA. 2009 Aug 19;302(7):741-9. doi: 10.1001/jama.2009.1198.
- Adjustment to cancer: Anxiety and distressLink provided by the sponsor.
- Cancer Facts and Figures 2025Link provided by the sponsor.
- Bringing Research to the Community to Reduce Cancer DisparitiesLink provided by the sponsor.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Survivorship Visit in people with Psychosocial Distress and Cancer, run by Ellis Medicine 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 7 inclusion and 5 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: enrolling by invitation, as of the sponsor's last update on 29 Jun 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?
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 Psychological Distress as Measured by the NCCN Distress Thermometer and Problem List (time frame: Baseline, 2 weeks after survivorship visit, and 1 month after survivorship visit). 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 NCT07673731, which also lists 10 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 Jun 2026.