Hematopoietic and Lymphoid Cell NeoplasmNCT04776941
Expressive Writing for the Management of Stress in Cancer Survivors
A study testing Behavioral Intervention, Quality-of-Life Assessment and Questionnaire Administration in people with Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This clinical trial evaluates the effect of expressive writing for the management of stress in cancer survivors. Cancer diagnosis and treatment are associated with increased stress in cancer survivors related to concerns about family, career, relationships, finances, side effects of treatment, and death. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Behavioral Intervention, Quality-of-Life Assessment and Questionnaire Administration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 414 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2020to 31 Dec 2028
- Phase
- Interventional
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
- At least 18 years old
- Have a diagnosis of cancer within the past 3 years
- Are able to speak and read in English
- Have access to a computer or smart phone with internet connection
- All disease sites and all cancer stages are eligible for enrollment
Who cannot join
- Inability to provide informed consent
- Non-English speakers will be excluded because this is a feasibility study that will enroll only a limited number of participants
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
Qian Lu, 713-745-8324, qlu@mdanderson.org
Qian Lu
About this study
Official title: COVID-19: A Virtual Feasibility Study to Manage Stress
This clinical trial evaluates the effect of expressive writing for the management of stress in cancer survivors. Cancer diagnosis and treatment are associated with increased stress in cancer survivors related to concerns about family, career, relationships, finances, side effects of treatment, and death. This stress can be further exacerbated by social upheavals such as the COVID-19 pandemic. For safety reasons, many patients are isolated with restricted access to in-person health care and reduced social interaction with family and friends. Together with the economic uncertainties that come with this pandemic, these factors are likely to increase cancer survivors' stress levels. Expressive writing may provide a medium through which cancer survivors confront stressors and find meaning in their experience. The goal of this trial is to learn more about the experiences of cancer survivors during stressful times.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate the feasibility of the virtual study for cancer survivors. II. To preliminarily assess the impact of the intervention for cancer survivors.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I (INTERVENTION): Patients complete questionnaires over 30 minutes about their mood, health, and income at baseline, and 1, 3, and 6 months. Patients also read brief positive messages and write essays about their experiences over 30 minutes (non-stop) once weekly (QW) for 3 weeks.
ARM II (CONTROL): Patients complete questionnaires over 30 minutes about their mood, health, and income at baseline, and 1, 3, and 6 months. Patients also read brief neutral messages and write essays about neutral topics over 30 minutes (non-stop) QW for 3 weeks.
- Being tested
- Behavioral Intervention, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral InterventionBehavioural
Also called Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy
Read positive messages
Behavioral InterventionBehavioural
Also called Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy
Write about positive experiences
Behavioral InterventionBehavioural
Also called Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy
Write about neutral topics
Behavioral InterventionBehavioural
Also called Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy
Read neutral messages
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Complete questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Arm I (questionnaires, messages, writing) | Experimental | Patients complete questionnaires over 30 minutes about their mood, health, and income at baseline, and 1, 3, and 6 months. Patients also read brief positive messages and write essays about their experiences over 30 minutes (non-stop) QW for 3 weeks. Receives: Behavioral: Behavioral Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
| Arm II (questionnaires, messages, writing) | Active comparator | Patients complete questionnaires over 30 minutes about their mood, health, and income at baseline, and 1, 3, and 6 months. Patients also read brief neutral messages and write essays about neutral topics over 30 minutes (non-stop) QW for 3 weeks. Receives: Behavioral: Behavioral Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant response rate
Measured: 1 month
Study completion rate
Measured: 1 month
Intervention adherence rate
Measured: 1 month
Secondary outcomes (4)
Change in stress
Perceived stress will be measured with the 4-item Perceived Stress Scale. Scale scores range from 0-16, with low scores indicating low perceived stress and high scores indicating high perceived stress
Measured: Baseline and 1-, 3-, and 6-month follow-up
Change in quality of life
Quality of life will be measured with the 7-item Functional Assessment of Cancer Therapy (FACT-G7). The items are rated on a 5-point scale from 0 - "not at all", to 4 - "very much". Scores range from 0-28, with higher scores indicating better quality of life.
Measured: Baseline and 1-, 3-, and 6-month follow-up
Change in physical health (sleep, fatigue, and cancer related morbidities)
Sleep will be measured with the 19-item Pittsburgh Sleep Quality Index (PSQI). The PSQI global score ranges from 0 to 21, with a cut-off score of 5 or greater indicating poor sleep quality.
Fatigue will be measured with the 4-item PROMIS Fatigue Short Form. This measure assesses the magnitude of fatigue in the past 7 days. Items are measured on a five-point scale (1= "not at all"; 5 = "very much") and summed. Higher scores indicate greater fatigue.
Cancer related morbidities will be self-reported by participants and verified through medical record review.
.
Measured: Baseline and 1-, 3-, and 6-month follow-up
Change in psychological health (depressive symptoms, anxiety, and fear of cancer recurrence)
Depressive symptoms will be measured with the 4-item PROMIS Depression Short Form. This measure assesses the frequency of depressive symptoms in the past 7 days. Items are measured on a five-point scale (1= "never"; 5 = "always") and summed. Higher scores indicate more depressive symptoms.
Anxiety will be measured with the 4-item PROMIS Anxiety Short Form. This measure assesses the frequency of anxiety in the past 7 days. Items are measured on a five-point scale (1= "never"; 5 = "always") and summed. Higher scores indicate greater anxiety.
Fear of cancer recurrence will be measured with a single item added to the quality of life measure (F
Measured: Baseline and 1-, 3-, and 6-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 posted2 Mar 2021
- Study start7 Aug 2020
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hematopoietic and Lymphoid Cell NeoplasmStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 414 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Qian Lu, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04776941
- Sponsor's protocol ID
- 2020-0538
- Other IDs
- NCI-2021-00218, 2020-0538
- Status last verified
- Aug 2026
- First submitted
- 9 Feb 2021
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Xu YA, Choi E, Wong-Meli CCY, Borjas M, Fei F, Mann S, Jin W, Dawkins-Moultin L, Lun D, Lu Q. Navigating rural challenges and promoting posttraumatic growth via expressive writing: a qualitative study among rural breast cancer survivors. Support Care Cancer. 2026 Sep 12;34(10):965. doi: 10.1007/s00520-026-11204-w.
PubMed 42730765Shin-Cho LJ, Dawkins-Moultin L, Choi E, Chen M, Barcenas CH, Roth M, Li Y, Lu Q. Feasibility Trial of an Online Expressive Writing Intervention for Young Adult Cancer Survivors. J Adolesc Young Adult Oncol. 2025 Aug;14(4):328-336. doi: 10.1089/jayao.2023.0187. Epub 2024 Oct 28.
PubMed 39466058