Clinical trial · Interventional
Addressing Cancer-Related Distress Through Survivorship Care in Community Oncology
NCT07673731CI-TRIAL-00116200enrolling by invitationN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Psychosocial Distress | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Structured Survivorship Visit | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Survivorship Visit Intervention
- description
- 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.
- interventionNames
- Behavioral: Structured Survivorship Visit
Primary outcomes (1)
- measure
- Change in Psychological Distress as Measured by the NCCN Distress Thermometer and Problem List
- timeFrame
- Baseline, 2 weeks after survivorship visit, and 1 month after survivorship visit
- description
- 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.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 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. Exclusion Criteria: 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
References
Publications (10)
- BACKGROUNDYusufov 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. PMID 37672598
- BACKGROUNDTemel 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. PMID 20818875
- BACKGROUNDPenedo 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. PMID 37342038
- BACKGROUNDOwnby KK. Use of the Distress Thermometer in Clinical Practice. J Adv Pract Oncol. 2019 Mar;10(2):175-179. Epub 2019 Mar 1. PMID 31538028
- BACKGROUNDMollica MA, Doose M, Reed C, Tonorezos E. Defining concepts in cancer survivorship. Cancer. 2025 Aug 15;131(16):e70039. doi: 10.1002/cncr.70039. PMID 40810248
- BACKGROUNDMehari 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. PMID 40753208
- BACKGROUNDHong 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.