NCT02723799

Brief Summary

This study aims to: I. Develop and pilot test the effectiveness of a Hope Promotion Program compared with the standard treatment protocol, in hope, comfort and quality of life, based on a population of palliative patients followed at Oncology day care unit. II. Evaluate perceptions and acceptability of Hope Promotion Program among palliative patients submitted to the intervention program.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2012

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

Study Start

First participant enrolled

January 1, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

March 14, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 30, 2016

Completed
Last Updated

January 9, 2023

Status Verified

January 1, 2023

Enrollment Period

6 months

First QC Date

March 14, 2016

Last Update Submit

January 5, 2023

Conditions

Keywords

HopeQuality of LifeComfort

Outcome Measures

Primary Outcomes (1)

  • Hope measured by the Portuguese version of Herth Hope Index

    Hope is measured by the Portuguese version of Herth Hope Index for chronic conditions (HHI-PT-DC). The HHI-PT-DC is a 10 item (1-4 point) Likert scale that delineates two sub-scales of hope: a) temporality, trust and interconnection, b) positive readiness and expectancy. The HHI-PT-DC takes approximately 5 minutes to complete. Summative scores range from 10-40, with a higher score denoting greater hope.

    Change from baseline at day 15 and 30

Secondary Outcomes (2)

  • Comfort measured by Portuguese version of Hospice Comfort Questionnaire

    Change from baseline at day 15 and 30

  • Quality of Life measured by the Portuguese version of McGill Quality of Life Questionnaire (MQOL-PT-DC)

    Change from baseline at day 15 and 30

Study Arms (2)

Hope Promotion Program (HPP)

EXPERIMENTAL

Plus to the standard treatment protocol, all the participants in this group attend the HPP, consisting of a three individual session's carried out by the nurse in patients' homes. It includes viewing the film Hopeful Living, enrolling in a hope activity from the Hope activity book, a relaxation activity and a negotiated plan to exercise hope in a regular basis.

Behavioral: Hope Promotion Program (HPP)Other: Standard Treatment Protocol

Standard Treatment Protocol

OTHER

Participants in this group has not access to a hope intervention. Data collection for outcome variables is the same as the participants in the other arms.

Other: Standard Treatment Protocol

Interventions

HPP is based on literature review and qualitative research in hope at the end-of-life. The film "Hopeful living" reflects the findings of the grounded theory study. Hope activity book is the final product of the literature review on hope interventions and its activities were tested in their feasibility and suitability in our previous research with persons with advanced cancer and their families.

Hope Promotion Program (HPP)

Regular assessment and care by the hospital outpatient health care team.

Hope Promotion Program (HPP)Standard Treatment Protocol

Eligibility Criteria

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

You may qualify if:

  • Portuguese speaking
  • Have a chronic advanced disease non-responding to treatment, metastatic disease, episodes of non-controlled symptoms
  • Have health care assistance by a health care team in an outpatient setting
  • Cognitive ability to answer the questionnaires (MMSE\>15 for illiterate participants, \>22 for participants with 11 years of schooling, \>27 for participants with more than 11 years of schooling)
  • Consenting to voluntarily participate in the study.

You may not qualify if:

  • Patients with high suffering from uncontrolled and recurrent presence of symptoms (nausea, vomiting, pain),
  • Patients with performance status under 30, due to their particularly vulnerability, intervention would need energy required to vital functions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Ryan RE, Connolly M, Bradford NK, Henderson S, Herbert A, Schonfeld L, Young J, Bothroyd JI, Henderson A. Interventions for interpersonal communication about end of life care between health practitioners and affected people. Cochrane Database Syst Rev. 2022 Jul 8;7(7):CD013116. doi: 10.1002/14651858.CD013116.pub2.

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

March 14, 2016

First Posted

March 30, 2016

Study Start

January 1, 2012

Primary Completion

July 1, 2012

Study Completion

October 1, 2013

Last Updated

January 9, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share