ACTION: cancer patient involvement in medical decision making

Phase 3

Completed

• Conditions: Topic: Cancer; Subtopic: Colorectal Cancer, Lung Cancer; Disease: Colon, Lung (small cell), Lung (non-small cell); Cancer

• Registration Number: ISRCTN63110516
• Lead Sponsor: ancaster University (UK)

Brief Summary

2016 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/27059593 protocol 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31672145 focus group results (added 04/11/2019) 2020 Other publications in https://pubmed.ncbi.nlm.nih.gov/31663183/ coping strategies of patients (added 07/10/2020) 2020 Results article in https://doi.org/10.1371/journal.pmed.1003422 results (added 02/12/2020) 2021 Other publications in https://pubmed.ncbi.nlm.nih.gov/33472621/ serious adverse event reporting procedures (added 22/01/2021) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36515362/ Healthcare use and healthcare costs (added 16/12/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-10-03
• Study Completion: 2018-11-30
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1117

Inclusion Criteria

Adult patients with advanced stages of lung or colorectal cancer. Patients need to have an estimated life expectancy of at least three months. The patients will be under the care of the oncologist at the participating hospitals.

Histologically confirmed diagnosis of:
1. Lung cancer:
2. Small cell extensive disease/ Stage III or IV*
3. Nonsmall cell stage III or IV*
4. Colorectal cancer: Stage IV *
*according to 7th edition of TNM classification and staging system
5. Written informed consent to participate
6. World Health Organisation performance status of 3 or under

Exclusion Criteria

1. Age less than 18 years
2. Unable to provide consent
3. Unable to complete questionnaire in country's language
4. Less than 3 months anticipated life expectancy
5. Taking part in a research study that is evaluating palliative care services or communication strategies

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of life and symptoms; Timepoint(s): Baseline, 10-12 and 18-20 weeks (both control and intervention group)

Secondary Outcome Measures

Name	Time	Method
<br> 1. Coping with their illness; Timepoint(s): Baseline, 10-12 and 18-20 weeks (both control and intervention group)<br> 2. Decisional Quality and Patient Activation; Timepoint(s): Baseline, 10-12 and 18-20 weeks (both control and intervention)<br> 3. Satisfaction with care; Timepoint(s): Baseline, 10-12 and 18-20 weeks (both control and intervention group)<br> 4. Satisfaction with the intervention; Timepoint(s): 10-12 and 18-20 weeks (intervention group only)<br>