Adapting and Pilot Testing a Loneliness Intervention for Cancer Survivors

Loneliness, which is the perceived lack of social support and connection, has increased substantially in the past decade and is adversely affecting the health and wellbeing of cancer survivors. The study seeks to test an intervention that builds on the principles of social prescribing, and targets loneliness to determine if it improves overall wellness and quality of life among cancer survivors.

Study Overview

• Status: Enrolling by invitation
• Conditions: Loneliness; Cancer Survivorship
• Intervention / Treatment: Behavioral: Social Prescribing Group; Behavioral: Usual Care

Detailed Description

Our primary study question for our pilot is: "Is it feasible to test a social prescribing intervention adapted to the unique needs of cancer survivors?"

The team will conduct a pilot study that will adapt and test the feasibility of implementing a social prescribing intervention to connect participants with social opportunities and develop supportive social networks.

Specific aims:

1. To adapt a social prescribing loneliness intervention for adult cancer survivors
2. To assess the feasibility of implementing a social prescribing intervention to address loneliness in adult cancer survivors in a 2-arm RCT

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98105
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18 years of age or older
• English-speaking
• A score greater or equal to 6 on the UCLA Loneliness 3-item Scale
• Cancer survivor with a cancer diagnosis

Exclusion Criteria:

• Are on palliative care or live in a controlled setting (i.e., assisted living, nursing home or inpatient treatment facility)
• Have an upcoming scheduled surgery
• Severe cognitive impairment or active psychosis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Social Prescribing Group; Participants will be randomized to the Social Prescribing group (N=18). Social Prescribing group participants will meet for 60 mins via Zoom, for 9-weeks.	Behavioral: Social Prescribing Group; Those in the Social Navigation intervention group will meet with the facilitator through a virtual visit (HIPAA-compliant videoconferencing or phone call based on patient preference) over the course of 9 weeks. Each virtual visit will last approximately 60 minutes. During the group intake visit, the facilitator will guide participants to complete an inventory of the participant's existing social network, former social network, and interests. Using this, in the second visit, the facilitator will work with the participants one-on-one to develop an action plan to promote, establish or re-establish social connections. The action plan will be referenced and refined throughout the course of the following 7 weeks. They will suggest specific social activities and connect patients to resources such as, community-based organizations or local social groups matched to individual participant interest to assist with social connection.
Experimental: Usual Care Group; Participants will be randomized to the Usual Care group (N=18). Participants in this group will resume to their usual standard of care for 9 weeks.	Behavioral: Usual Care; Those randomized to the Usual Care group will receive usual care from their primary care clinician. At the conclusion of the study (after the final outcomes are collected), they will be offered a list of possible community-based organizations for social connection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Loneliness	The primary outcome is to see changes in loneliness using the University of California, Los Angeles Loneliness Version 3 (UCLA). It contains 20 questions that ask about loneliness-related experiences. Loneliness score range 0-80 with 80 indicating a maximum value and severe loneliness.	Baseline, 9 Weeks, 2 Month Follow Up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Social Connection	The Lubben Social Network Scale - 6 contains 6 questions that ask about interaction and trust with family and friends in the past month. The scale is scored from 0 to 30 with each question asking about number of friends or family "seen or heard from at least once a month," "at ease with that you could talk about private matters" or "close to such that you could call on them for help" on a ranked scale of 0 (none) to 5 (9 or more).	Baseline, 9 Weeks, 2 Month Follow Up
Self-Efficacy	Self-efficacy is the belief in one's ability to cope with a broad range of stressful and challenging demands. The Generalized Self-Efficacy Scale has 10 items with questions about ability to cope and problem solve with responses ranging from 0 (not at all true) to 4 (exactly true).	Baseline, 9 Weeks, 2 Month Follow Up
Quality of Life Core 30	The European Organisation for Research and Treatment of Cancer Quality of Life Core 30 (EORTC-QOL-C30) contains 30 questions that ask about activities of daily living, symptomatology, overall health and quality of life.	Baseline, 9 Weeks, 2 Month Follow Up
PHQ-9	The Patient Health Questionnaire-9 (PHQ-9) contains 9 questions that ask about the frequency of depression-related symptoms over the past two weeks. Response options range from 0 (Not at all) to 3 (Nearly every day), with higher scores indicating greater symptom severity.	Baseline, 9 Weeks, 2 Month Follow Up
GAD-7	The Generalized Anxiety Disorder-7 (GAD-7) contains 7 questions that ask about the frequency of anxiety-related symptoms over the past two weeks. Response options range from 0 (Not at all) to 3 (Nearly every day), with higher scores indicating greater symptom severity.	Baseline, 9 Weeks, 2 Month Follow Up

Collaborators and Investigators

• Sponsor: University of Washington
• Investigators: Principal Investigator: Sebastian Tong, MD, MPH, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: February 10, 2026
• First Submitted That Met QC Criteria: February 10, 2026
• First Posted (Actual): February 18, 2026

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00023577

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