NCT03446092

Brief Summary

The study will investigate whether a mindfulness course can help people with incurable cancer who are seen by oncologists in a particular National Health Service Hospital Trust in the United Kingdom.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable cancer

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 26, 2018

Completed
9 months until next milestone

Study Start

First participant enrolled

November 19, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2020

Completed
Last Updated

May 12, 2022

Status Verified

May 1, 2022

Enrollment Period

7 months

First QC Date

February 13, 2018

Last Update Submit

May 11, 2022

Conditions

Keywords

CancerMindfulnessPalliative care

Outcome Measures

Primary Outcomes (1)

  • Acceptability and usefulness of intervention for participants

    This will be a qualitative outcome, collected via semi-structured interview

    Within 4 weeks of the end of the intervention

Secondary Outcomes (7)

  • Acceptability and usefulness of intervention for participants- 3 months

    3 months following completion of the intervention

  • Change in depression anxiety and stress

    Collected before the intervention (up to 4 weeks before the intervention) and within 4 weeks of the end of the intervention

  • Change in depression anxiety and stress-3 months

    Collected before the intervention (up to 4 weeks before the intervention) and 3 months after the end of the intervention

  • Change in mindfulness

    Collected before the intervention (up to 4 weeks before the intervention) and within 4 weeks of the end of the intervention

  • Change in mindfulness- 3 months

    Collected before the intervention (up to 4 weeks before the intervention) and 3 months following the intervention

  • +2 more secondary outcomes

Study Arms (1)

Mindfulness group

EXPERIMENTAL

Group will receive mindfulness intervention

Behavioral: Mindfulness for health

Interventions

A course of mindfulness using the mindfulness for health programme.

Mindfulness group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Deemed by the oncologist to have incurable cancer
  • Patient of the University Hospitals of Morecambe Bay NHS Foundation Trust
  • Treated by an oncologist
  • Believe they are able to commit to attending most of the mindfulness course sessions
  • Oncologist assesses they are well enough to participate in the intervention

You may not qualify if:

  • Having any other condition or difficulty which the medical team thinks would compromise their participation in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Lancaster Infirmary

Lancaster, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms

Interventions

MindfulnessHealth

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesPopulation Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

February 13, 2018

First Posted

February 26, 2018

Study Start

November 19, 2018

Primary Completion

June 30, 2019

Study Completion

May 30, 2020

Last Updated

May 12, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations