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OpenTrials
Enrolling by Invitation

NCT Number: NCT07418437

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.

Enrolling by Invitation

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Key information

Conditions

Cancer Survivorship Loneliness

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Washington

Seattle, Washington, 98105, United States

About this study

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:

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

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Social Prescribing Group

Behavioral

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.

Usual Care

Behavioral

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.

Primary outcomes

  1. Loneliness

    Time frame: Baseline, 9 Weeks, 2 Month Follow Up

    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.

Secondary outcomes

  1. Social Connection

    Time frame: Baseline, 9 Weeks, 2 Month Follow Up

    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).

  2. Self-Efficacy

    Time frame: Baseline, 9 Weeks, 2 Month Follow Up

    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).

  3. Quality of Life Core 30

    Time frame: Baseline, 9 Weeks, 2 Month Follow Up

    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.

  4. PHQ-9

    Time frame: Baseline, 9 Weeks, 2 Month Follow Up

    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.

  5. GAD-7

    Time frame: Baseline, 9 Weeks, 2 Month Follow Up

    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.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 18, 2026
Registry last updated
Jun 4, 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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