Addressing Cancer-Related Distress Through Survivorship Care in Community Oncology

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.

Enrolling by Invitation

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Key information

Conditions

Psychosocial Distress Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ellis Medicine/Roswell Park Medical Oncology

Schenectady, New York, 12308, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Structured Survivorship Visit

Behavioral

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.

Primary outcomes

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.

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

Ellis Medicine

Other

Registry information

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Jun 29, 2026
Registry last updated: Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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