NCT02943174

Brief Summary

This investigation aims to apply and test the acceptability of an acceptance, mindfulness and compassionate-based intervention structured for cancer patients. MIND programme for cancer thus comprises 8 weekly group sessions, lasting 1 and a half hour each, run in small groups at an Oncology Service at the Coimbra's University Hospital. For each week participants have assigned homework (e.g., mindfulness exercises). This programme mainly aims to increase participants' physical and psychosocial quality of life, and attenuate depressed mood and anxiety.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at below P25 for not_applicable cancer

Timeline
Completed

Started Jun 2016

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 21, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 24, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

May 30, 2019

Status Verified

May 1, 2019

Enrollment Period

1.3 years

First QC Date

October 21, 2016

Last Update Submit

May 27, 2019

Conditions

Cancer

Outcome Measures

Primary Outcomes (2)

  • Changes in psychopathology (namely, depression and anxiety symptoms)

    Measured by DASS-21

    From Baseline to follow-up

  • Changes in Quality of Life

    Measured by the World Health Organization Quality of Life questionnaire (WHOQOL-BREF)

    From Baseline to follow-up

Study Arms (2)

MIND Programme for cancer

EXPERIMENTAL

MIND programme for cancer is a manualized acceptance, mindfulness and compassionate-based group intervention for cancer patients. It included 8 weekly group sessions, 2h hours each, run in small groups (ranging from 6 to 12 participants). Participants in this group also receive cancer treatment as usually performed at the Coimbra University Hospital.

Behavioral: MIND programme for cancer patientsOther: Treatment as Usual (TAU)

Treatment as Usual (TAU)

OTHER

Cancer treatment as usually performed at the Coimbra University Hospital.

Other: Treatment as Usual (TAU)

Interventions

MIND programme for cancer patientsBEHAVIORAL

Psychotherapeutic programme based on Acceptance, Mindfulness and Compassion for cancer patients Other: Cancer Treatment as Usual

MIND Programme for cancer
Treatment as Usual (TAU)OTHER

Standard personalized treatment of cancer

MIND Programme for cancerTreatment as Usual (TAU)

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of breast cancer (stages I-III)

You may not qualify if:

  • severe psychopathology
  • difficulty in completing self-report measures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neoplasms

Interventions

Therapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

October 21, 2016

First Posted

October 24, 2016

Study Start

June 1, 2016

Primary Completion

October 1, 2017

Study Completion

April 1, 2018

Last Updated

May 30, 2019

Record last verified: 2019-05