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Enrolling by invitation NCT07418437

Adapting and Pilot Testing a Loneliness Intervention for Cancer Survivors

No phase Interventional Cancer Survivorship Loneliness

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Social Prescribing Group, Usual Care.
Who it may be relevant to
Registry conditions: Cancer Survivorship, Loneliness. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

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

Interventions

  • 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
  • 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.

Primary outcome measures

  • Loneliness [Time frame: Baseline, 9 Weeks, 2 Month Follow Up]
Secondary outcome measures (5)
  • Social Connection [Time frame: Baseline, 9 Weeks, 2 Month Follow Up]
  • Self-Efficacy [Time frame: Baseline, 9 Weeks, 2 Month Follow Up]
  • Quality of Life Core 30 [Time frame: Baseline, 9 Weeks, 2 Month Follow Up]
  • PHQ-9 [Time frame: Baseline, 9 Weeks, 2 Month Follow Up]
  • GAD-7 [Time frame: Baseline, 9 Weeks, 2 Month Follow Up]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Washington — Seattle

Identifiers

NCT: NCT07418437 · STUDY00023577

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗