An expressive writing randomised controlled trial with colorectal cancer patients: A test of the underlying mechanism
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ABSTRACT: Interventions: This study tests an expressive writing intervention. Expressive writing is the writing of deep thoughts and feelings about a cancer diagnosis and treatment. Participants engage in 4 writing sessions of 30 minutes duration each, spaced one week apart. Participants are allocated to one of two groups: Intervention group or Waitlist control group. The Intervention group participates in the intervention up to 4 weeks post their final cancer treatment session. The intervention is carried out individually by participants in their own homes, with phone assistance from a research assistant.
Primary outcome(s): Improvement in physical symptoms and symptom distress (Symptom Experience Index)[Questionnaire is administered immediately prior to intervention, immediately after the intervention and at 4 months follow-up. The Waitlist control group fills out a questionnaire at timepoints identical to the Intervention group, plus an additional questionnaire immediately after their writing intervention.];Reduction in psychological distress[Questionnaire is administered immediately prior to intervention, immediately after the intervention and at 4 months follow-up. The Waitlist control group fills out a questionnaire at timepoints identical to the Intervention group, plus an additional questionnaire immediately after their writing intervention.];Anxiety and depression (Brief Symptom Inventory)[Questionnaire is administered immediately prior to intervention, immediately after the intervention and at 4 months follow-up. The Waitlist control group fills out a questionnaire at timepoints identical to the Intervention group, plus an additional questionnaire immediately after their writing intervention.];Increase in post-traumatic growth (Post-traumatic Growth Inventory)[Questionnaire is administered immediately prior to intervention, immediately after the intervention and at 4 months follow-up. The Waitlist control group fills out a questionnaire at timepoints identical to the Intervention group, plus an additional questionnaire immediately after their writing intervention.]
Study Design: Purpose: Educational / counselling / training; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy
DISEASE(S): Colorectal Cancer,Cancer-bowel-back Passage (rectum) Or Large Bowel (colon)
PROVIDER: 2452799 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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