Cancer SurvivorsNCT06282471
EW and Self-Guided PST in Cancer Survivors and Caregivers
A study testing Expressive Writing and Problem-Solving Therapy (EW+PST) in people with Cancer Survivors and Informal Caregivers, run by Virginia Commonwealth University.
Trial summary
To assess the feasibility and acceptability of expressive writing + problem solving therapy (EW+PST) among cancer survivors and informal caregivers Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Survivors, Informal Caregivers
- What is being tested?
- Expressive Writing and Problem-Solving Therapy (EW+PST)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 21 Feb 2024to 14 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Cancer diagnosis of any type OR informal caregiver (family member, friend, and/or spouse who provides the majority of caregiving) of someone with cancer
- Patient of Virginia Commonwealth University (VCU) Massey Cancer Center OR informal caregiver (family member, friend, and/or spouse) of a VCU Massey Cancer Center patient
Who cannot join
- Physical inability to write
- Non-English speaker/writer
- Inability to consent to study participation
About this study
Official title: Expressive Writing (EW) and Self-Guided Problem-Solving Therapy (PST) in Cancer Survivors and Caregivers
To assess the feasibility and acceptability of expressive writing + problem solving therapy (EW+PST) among cancer survivors and informal caregivers
Read the detailed description
This is a single-arm proof-of-concept behavioral clinical trial of a self-guided expressive writing and problem-solving therapy intervention for adult cancer survivors and adult informal caregivers thereof
- Conditions
- Cancer Survivors, Informal Caregivers
- Being tested
- Expressive Writing and Problem-Solving Therapy (EW+PST)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expressive Writing and Problem-Solving Therapy (EW+PST)Behavioural
Participants will undergo a 6-week self-guided EW+PST. Participants will be provided with 6 printed journals (one for each week of the study) and instructed to write at least 2 entries per week.
| Study group | Role | What they receive |
|---|---|---|
| Expressive Writing and Problem-Solving Therapy | Experimental | Self-guided expressive writing and problem-solving therapy intervention for adult cancer survivors and adult informal caregivers thereof Receives: Behavioral: Expressive Writing and Problem-Solving Therapy (EW+PST) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consent Rate
Number of eligible individuals who choose to enroll in the study over the total number of eligible individuals.
Measured: Day 1
Study Retention
Study retention will be analyzed as the number of participants completing the 6-week questionnaires
Measured: Week 6
Completed Journal Entries
Number of completed journal entries will be tabulated from returned participant journals.
Measured: Week 6
Patient Satisfaction Questionnaire
The number of participants that are satisfied with the intervention. Participants will be asked about their satisfaction with the program including perceived efficacy and suggestions for improvement
Measured: Baseline, Week 6
Secondary outcomes (10)
Change in Post Traumatic Growth Inventory (PTGI) Score from 0 to 6 weeks
The PTGI is a 21-item scale designed to assess individual growth following the experience of a traumatic experience, e.g. cancer. The items load onto 5 factors: personal strength, new possibilities, improved relationships, spiritual growth, and appreciation for life.Items are rated 0-5 and a total score is calculated by summing the responses to all items. Higher scores represent greater post-traumatic growth. There are also 5 factors which are scored by summing the items associated with each factor: Relating to Others; New Possibilities; Personal Strength; Spiritual Change; Appreciation of Life. Higher factor scores represent higher levels of each factor.
Measured: Baseline, Week 6
Change in European Organization for the Research and Treatment of Life Questionnaire (EORTC QLQ-30) Score from 0 to 6 weeks
This measure consists of both multi-item and single-item scales. Raw scores are calculated for each scale, then transformed using linear transformation to standardize the raw score so that scores range from 0-100. Higher scores on functioning and quality of life scales represent better functioning/quality of life; higher scores on symptom scales represent worse functioning/quality of life.
Measured: Baseline, Week 6
Change in Patient Health Questionnaire-8 (PHQ-8) Score from 0 to 6 Weeks
The Patient Health Questionnaire-8 (PHQ-8) is an 8-item measure developed for use in clinical and research settings to assess symptoms of depression. Scores can be categorized into mild, moderate, and severe symptom severity. Items are rated 0-3 and a total score is calculated by summing the responses to all items. Higher scores represent greater symptoms of depression.
Measured: Baseline, Week 6
Change in Perceived Stress Scale-10 item (PSS-10) Score from 0 to 6 Weeks
The PSS-10 is a 10-item scale used to assess self-reported stress. Items are scored 0-4 and a total score is calculated by summing the responses to all items. Higher scores represent greater perceived stress.
Measured: Baseline, Week 6
Change in New General Self-Efficacy Scale (GSES-N) Score from 0 to 6 Weeks
The New General Self-Efficacy Scale (GSES-N) is an 8-item measure that assesses how much people believe that they can achieve their goals despite encountering barriers, challenges, or difficulties. Items are scored 1-5 and a total score is calculated by averaging the responses to all items. Higher scores represent greater perceived self-efficacy.
Measured: Baseline, Week 6
Change in Multidimensional Scale of Perceived Social Support (MSPSS) Score from 0 to 6 Weeks
The MSPSS is a 12-item questionnaire of perceived social support from three sources: family, friends, and significant other. Items are scored 1-7 and a total score is calculated by averaging the responses to all items. There are also 3 subscales whose scores are calculated by averaging the responses to the associated items: Significant Other; Family; Friends. Higher scores represent greater perceived social support in total and for each subscale.
Measured: Baseline, Week 6
Change in Family Environment Scale-Revised (FES-R) Score from 0 to 6 Weeks
The FES-R is a 27-item true/false measure designed to characterize social and environmental characteristics of families: Cohesion, expressiveness, and conflict, The FES items are arranged so that each column of responses on the answer sheet constitutes one subscale. The number of responses given in the keyed direction as identified on the scoring key in each column, and enter the total in the raw score (RS) box at the bottom. (it's added, some are reverse coded). To determine the family's mean RS for each subscale, average the subscale raw scores for all members of that family. Relationship-Oriented Families. These families cannot be categorized as personal growth-oriented and have at least one elevated subscale within the relationship domain. Relationship-oriented families include: Ø Support-oriented families (15.3 percent; cohesion or expressiveness or both ≥ 60 and either cohesion or expressiveness ≥ conflict) Ø Conflict-oriented families (5.2 percent; conflict ≥ 60)
Measured: Baseline, Week 6
Change in Cancer Communication Assessment Tool for Patients and Families (CCAT-PF) Score from 0 to 6 Weeks
The CCAT-PF is an 18-item questionnaire that assesses congruence in patient-family caregiver communication; there are parallel versions of the instrument for patients and family members. Items are scored 1-6 and a total score is calculated by summing the responses to all items. Higher scores indicate greater perceived conflict.
Measured: Baseline, Week 6
Change in Caregiver Burden Scale (CBS) Score from 0 to 6 Weeks
The CBS is a 22-item self-report measure that assesses perceptions of burden related to providing care to someone with a chronic illness. The CBS has 5 factors: general strain, isolation, disappointment, emotional involvement, and environment. Items are scored 0-4 and a total score is calculated by summing the responses to all items. Higher scores indicate greater perceived burden.
Measured: Baseline, Week 6
Change in EORTC Quality of Life Core Scale (EORTC QLQ-30) Score from 0 to 6 Weeks
The EORTC QLQ-30 is a 30-item self-report measure designed to assess health-related quality of life of cancer patients enrolled in clinical trials. It consists of both multi-item and single-item scales with higher scores reflecting higher scale value: for example, a high score on a symptom scale reflects higher symptom burden; a high score on a functional scale represents a higher level of functioning. The average raw score for each scale is transformed so that it falls within a range from 0 to 100.
Measured: Baseline, Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start21 Feb 2024
- Primary completion14 May 2025
- Study completion14 May 2025
Why it stopped: Not feasible
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer SurvivorsStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susan Hong, MD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06282471
- Sponsor's protocol ID
- MCC-23-20794
- Other IDs
- HM20028614
- Status last verified
- Jun 2025
- First submitted
- 21 Feb 2024
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expressive Writing (EW) and Self-Guided Problem-Solving Therapy (PST) in Cancer Survivors and Caregivers
- ClinicalTrials.gov ID
- NCT06282471
- Acronym / sponsor ID
- MCC-23-20794
- Conditions
- Cancer Survivors, Informal Caregivers
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not feasible
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 21 Feb 2024 (actual)
- Primary completion
- 14 May 2025 (actual)
- Study completion
- 14 May 2025 (actual)
- First posted
- 28 Feb 2024 (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.
To assess the feasibility and acceptability of expressive writing + problem solving therapy (EW+PST) among cancer survivors and informal caregivers
Detailed description
This is a single-arm proof-of-concept behavioral clinical trial of a self-guided expressive writing and problem-solving therapy intervention for adult cancer survivors and adult informal caregivers thereof
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Expressive Writing and Problem-Solving Therapy | Experimental | Behavioral: Expressive Writing and Problem-Solving Therapy (EW+PST)Self-guided expressive writing and problem-solving therapy intervention for adult cancer survivors and adult informal caregivers thereof |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Cancer diagnosis of any type OR informal caregiver (family member, friend, and/or spouse who provides the majority of caregiving) of someone with cancer
- Patient of Virginia Commonwealth University (VCU) Massey Cancer Center OR informal caregiver (family member, friend, and/or spouse) of a VCU Massey Cancer Center patient
Key exclusion criteria (3 listed)
- Physical inability to write
- Non-English speaker/writer
- Inability to consent to study participation
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 |
|---|---|---|
| Expressive Writing and Problem-Solving Therapy (EW+PST)Participants will undergo a 6-week self-guided EW+PST. Participants will be provided with 6 printed journals (one for each week of the study) and instructed to write at least 2 entries per week. | Behavioural | Expressive Writing and Problem-Solving Therapy |
Primary outcome
Consent Rate
Time frame: Day 1
Number of eligible individuals who choose to enroll in the study over the total number of eligible individuals.
Study Retention
Time frame: Week 6
Study retention will be analyzed as the number of participants completing the 6-week questionnaires
Completed Journal Entries
Time frame: Week 6
Number of completed journal entries will be tabulated from returned participant journals.
Patient Satisfaction Questionnaire
Time frame: Baseline, Week 6
The number of participants that are satisfied with the intervention. Participants will be asked about their satisfaction with the program including perceived efficacy and suggestions for improvement
10 secondary outcomes
Change in Post Traumatic Growth Inventory (PTGI) Score from 0 to 6 weeks
Time frame: Baseline, Week 6
Change in European Organization for the Research and Treatment of Life Questionnaire (EORTC QLQ-30) Score from 0 to 6 weeks
Time frame: Baseline, Week 6
Change in Patient Health Questionnaire-8 (PHQ-8) Score from 0 to 6 Weeks
Time frame: Baseline, Week 6
Change in Perceived Stress Scale-10 item (PSS-10) Score from 0 to 6 Weeks
Time frame: Baseline, Week 6
Change in New General Self-Efficacy Scale (GSES-N) Score from 0 to 6 Weeks
Time frame: Baseline, Week 6
Change in Multidimensional Scale of Perceived Social Support (MSPSS) Score from 0 to 6 Weeks
Time frame: Baseline, Week 6
Change in Family Environment Scale-Revised (FES-R) Score from 0 to 6 Weeks
Time frame: Baseline, Week 6
Change in Cancer Communication Assessment Tool for Patients and Families (CCAT-PF) Score from 0 to 6 Weeks
Time frame: Baseline, Week 6
Change in Caregiver Burden Scale (CBS) Score from 0 to 6 Weeks
Time frame: Baseline, Week 6
Change in EORTC Quality of Life Core Scale (EORTC QLQ-30) Score from 0 to 6 Weeks
Time frame: Baseline, Week 6
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for Cancer Survivors
Recruiting
Facial Expression Awareness Training to Understand and Recognize Emotions
Survivors of Pediatric Brain Tumors, Pediatric Cancer
Not yet recruiting
Evaluation of Massage Therapy for Cancer Related Fatigue in Breast Cancer Survivors
Breast Cancer, Fatigue in Cancer Survivors
Active, not recruitingObservational study
A Study of Attention and Memory Processes in Breast Cancer Survivors
Breast Cancer Survivors
Not yet recruiting
Multi-level Intervention to Successfully Transition to Adult Care for Survivors of Childhood and Adolescent Cancers: The BRIDGES-YAS! Study
Health Care Transition, Survivorship Care
Active, not recruitingObservational study
Evaluation of an Online, Remote Cognitive Battery for Use in Cancer Survivorship
Breast Cancer Survivors
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. This study is not recruiting at the moment.
Susan Hong, MD principal investigator
Virginia Commonwealth University
Questions about this trial
What is this clinical trial studying?
A study testing Expressive Writing and Problem-Solving Therapy (EW+PST) in people with Cancer Survivors and Informal Caregivers, run by Virginia Commonwealth University.
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 2 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: withdrawn, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Consent Rate (time frame: Day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jun 2025; AzTrials last refreshed its copy on 8 Nov 2026.