Addressing Cancer-Related Distress Through Survivorship Care in Community Oncology

June 23, 2026 updated by: Dr.Tallat Mahmood,MD, Ellis Medicine

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Schenectady, New York, United States, 12308
        • Ellis Medicine/Roswell Park Medical Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Survivorship Visit Intervention
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.
Behavioral: Structured Survivorship Visit
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 2 weeks after survivorship visit, and 1 month after survivorship visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
Baseline, 2 weeks after survivorship visit, and 1 month after survivorship visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ellis Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

June 23, 2026

First Submitted That Met QC Criteria

June 23, 2026

First Posted (Actual)

June 29, 2026

Study Record Updates

Last Update Posted (Actual)

June 29, 2026

Last Update Submitted That Met QC Criteria

June 23, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00008111-04302026-MAH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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