Mindfulness-oriented Recovery Enhancement (MORE) for Cancer Pain Relief

Chronic Pain Clinical Trial

Official title:

Adapting Mindfulness-oriented Recovery Enhancement (MORE) for Cancer Pain Relief: The MORE Relief Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05877521
• Other study ID #: 23-082
• Status: Recruiting
• Phase: Phase 2
• Start date: May 16, 2023
• Est. completion date: May 16, 2027

Study information

• Verified date: April 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Jun Mao, MD, MSCE
• Phone: 646-608-8552
• Email: maoj[@]mskcc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate whether or not mindfulness-based interventions/MBIs may help reduce chronic pain in participants who have cancer-related chronic pain. MBIs are therapeutic programs that use mindfulness meditation practices to help people focus on the present moment, as well as encourage acceptance of thoughts, emotions, and body sensations. The researchers think that an MBI treatment called Mindfulness-oriented Recovery Enhancement (MORE) may help people who are experiencing cancer-related chronic pain.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: May 16, 2027
• Est. primary completion date: May 16, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• English speaking

• Age = 18 years or older

• A history of cancer with no restrictions placed on type of cancer

• Determined to be either no-evidence of disease or stable oncological disease by referring or study physicians/advanced practice providers

• Having a pain (musculoskeletal, generalized, or neuropathic) rating of 4 or greater in worst pain on a 0-10 numerical rating scale in the preceding week

• Having had pain for at least 3 months and at least 15 days with pain in the preceding 30 days

• Willing to adhere to all study-related procedures, including randomization to one of two treatment arms: MORE or WLC

• Ability to attend video-call session and a quiet/private location

Exclusion Criteria:

• Active suicidality or schizophrenia

• Plan to initiate palliative radiation or interventional pain procedure within the next 12 weeks

• Cognitive impairment preventing completing PRO independently or participate in virtual MORE as evaluated by study clinicians

Related Conditions & MeSH terms

• Cancer Pain
• Chronic Pain

Intervention

Behavioral:
• MORE treatments
MORE participants will also be asked to engage in 15 minutes/day of skill practice at home, and complete daily diaries of mindfulness practice time

Other:
• Standard of Care for Pain Management
Participants in the WLC group continue to receive their standard medical care and pain management as prescribed by their physicians or other health care providers.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center (All Protocol Activities)	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of participant enrollment to the study	Feasibility of the intervention will be determined by Rate of participant enrollment to the study	12 months

External Links

•   Memorial Sloan Kettering Cancer Center