Investigating the Impact of Tailored Reports on Anxiety
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- University of Plymouth
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- use of booklet with others between intervention and three month follow up
Study Overview
Brief Summary
Objective: To explore the hypothesis that different methods of selecting and printing information for cancer patients could improve emotional support by affecting interaction with others, and so lead to improved psychological wellbeing.
Design: Randomised trial with 8 groups (three factors, 2X2X2). Data collected at recruitment and three month follow-up.
Participants: 400 patients starting radiotherapy and their 'confidant' (the person in who they confide).
Interventions: Printed booklets.
- Half had 'general' CancerBACUP information for that cancer; half had 'personal' information from the medical record plus selected general information;
- Half chose information by 'interacting' with the computer; half had a larger volume of material in booklets that were produced 'automatically'.
- Half had additional 'anxiety management advice'.
Outcomes: Patients' views; use of booklet with others; change in reported social support; change in anxiety and depression.
Detailed Description
Aim:
- Based on a randomised trial the researchers aimed to model use of leaflets in the home as a function of three factors:
- whether patients chose the information themselves or if it was chosen for them;
- whether it included personal information from their own medical record or not;
- whether it included anxiety management advice or not.
- The researchers aimed to model patient and confidant's anxiety at three months as a function of these three factors and patients' use of leaflets in the home.
Patient Population: Beatson Oncology Centre (BOC). Patients thought to be eligible were to be identified from outpatient appointment diaries over fifteen months. Medical records were to be checked for all those initially identified to ensure that patients have breast, gynaecological, prostate or bladder or testicular, or selected cancers of the head or neck. Patients excluded were to be those:
- receiving palliative treatment,
- with no knowledge or understanding of their diagnosis (very few),
- with visual or mental handicap,
- with severe pain or symptoms causing distress,
- medical or nursing students,
- taking part in other trials with possibly confounding interventions, and
- those not giving informed consent.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients starting outpatient radiotherapy treatment with breast, prostate, cervical or laryngeal cancer
Exclusion Criteria
- •Receiving palliative care
- •Severe pain or symptoms causing distress
- •Having cancer at other sites
- •Having no spoken English
- •Receiving treatment for psychological or psychiatric problems
- •Visual or mental handicap
- •Having case notes not available or ambiguous or illegible.
Outcomes
Primary Outcomes
use of booklet with others between intervention and three month follow up
change in reported social support between recruitment and three month follow up
change in anxiety and depression between recruitment and three month follow up
patients' views three months after intervention
Secondary Outcomes
- confidants' views three months after intervention
- change in confidants' anxiety and depression between recruitment and three month follow up