Cancer SurvivorshipNCT07418437
Adapting and Pilot Testing a Loneliness Intervention for Cancer Survivors
A study testing Social Prescribing Group in people with Cancer Survivorship and Loneliness, run by University of Washington at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Survivorship, Loneliness
- What is being tested?
- Social Prescribing Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2026to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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:
- 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
- Conditions
- Cancer Survivorship, Loneliness
- Being tested
- Social Prescribing Group, Usual Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social Prescribing GroupBehavioural
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 CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Social Prescribing Group | Experimental | 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. Receives: Behavioral: Social Prescribing Group |
| Usual Care Group | Experimental | 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. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 9 Weeks, 2 Month Follow Up
Secondary outcomes (5)
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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 9 Weeks, 2 Month Follow Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start9 Mar 2026
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer SurvivorshipStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sebastian Tong, University of Washington
- Investigators
- Sebastian Tong, MD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07418437
- Sponsor's protocol ID
- STUDY00023577
- Status last verified
- Feb 2026
- First submitted
- 10 Feb 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ike B, Cole A, Keiser B, Tu A, Holcroft M, Tong S. An adapted enhanced social prescribing intervention vs. usual care in the treatment of loneliness in cancer survivors: Study protocol for a feasibility pilot randomized controlled trial. PLoS One. 2026 Sep 18;21(9):e0350956. doi: 10.1371/journal.pone.0350956. eCollection 2026.
PubMed 42758733
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting and Pilot Testing a Loneliness Intervention for Cancer Survivors
- ClinicalTrials.gov ID
- NCT07418437
- Acronym / sponsor ID
- STUDY00023577
- Conditions
- Cancer Survivorship, Loneliness
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 9 Mar 2026 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Social Prescribing Group | Experimental | Behavioral: Social Prescribing GroupParticipants will be randomized to the Social Prescribing group (N=18). Social Prescribing group participants will meet for 60 mins via Zoom, for 9-weeks. |
| Usual Care Group | Experimental | Behavioral: Usual CareParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social Prescribing GroupThose 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. | Behavioural | Social Prescribing Group |
| Usual CareThose 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. | Behavioural | Usual Care Group |
Primary outcome
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Derived from this study: PubMed 42758733Ike B, Cole A, Keiser B, Tu A, Holcroft M, Tong S. An adapted enhanced social prescribing intervention vs. usual care in the treatment of loneliness in cancer survivors: Study protocol for a feasibility pilot randomized controlled trial. PLoS One. 2026 Sep 18;21(9):e0350956. doi: 10.1371/journal.pone.0350956. eCollection 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sebastian Tong, MD, MPH principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social Prescribing Group in people with Cancer Survivorship and Loneliness, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Loneliness (time frame: Baseline, 9 Weeks, 2 Month Follow Up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07418437, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.