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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.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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)
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

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 groups in NCT06282471
Study groupRoleWhat they receive
Expressive Writing and Problem-Solving TherapyExperimentalSelf-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.

  1. Consent Rate

    Number of eligible individuals who choose to enroll in the study over the total number of eligible individuals.

    Measured: Day 1

  2. Study Retention

    Study retention will be analyzed as the number of participants completing the 6-week questionnaires

    Measured: Week 6

  3. Completed Journal Entries

    Number of completed journal entries will be tabulated from returned participant journals.

    Measured: Week 6

  4. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  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

  7. 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

  8. 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

  9. 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

  10. 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.

  1. First posted28 Feb 2024
  2. Study start21 Feb 2024
  3. Primary completion14 May 2025
  4. Study completion14 May 2025

Why it stopped: Not feasible

Resources

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)
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

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.

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