NCT03466762

Brief Summary

The main aim of this study is to evaluate the impact of head \& neck cancer and brain tumors on lives of patients in Pakistan. To the best of the investigators knowledge this will be the first in-depth study to evaluate resilience and quality of life (QoL) among this group of patients. These patients encounter challenges as they battle to maintain optimistic outlook towards life. Resilience and QoL among them changes over time and may be modifiable towards increased well-being. Resilience and QoL are critical components during diagnosis, treatment, survivorship, and at the end of life. Hence, these are important traits for promoting positive psychological well-being. Through this study the investigators will be able to identify problems faced by such patients in our setting. the investigators will be able to plan appropriate interventions to improve a person's resiliency and quality of life, reduce depression and anxiety, and increase their satisfaction with life. This study is also aimed to inform healthcare providers and researchers regarding protective or risk characteristics for coping with cancer. Practices and resilience interventions may improve well-being and adherence to care guidelines. The objectives of our study are: Primary Objectives:

  • To determine resilience and quality of life scores after treatment separately for head \& neck cancer and Brain tumor patients in Pakistan.
  • To evaluate important factors associated with resilience and quality of life after treatment separately for head \& neck cancer and Brain tumor patients in Pakistan. Secondary Objective:
  • To examine the relationship between resilience and quality of life after treatment separately for head \& neck cancer and Brain tumor patients in Pakistan. It will be an analytical cross sectional study design. The study will be conducted at the Aga Khan University Hospital, Karachi. Study participants will be men and women greater than 18 years, with brain tumors or head \& neck cancer fulfilling the eligibility criteria. Approximately 250 patients will be recruiting with brain tumors and 250 with head \& neck cancer. Validated tools will be used to measure resilience and QoL.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2018

Shorter than P25 for all trials

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

March 1, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 15, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

January 9, 2020

Status Verified

January 1, 2020

Enrollment Period

8 months

First QC Date

March 1, 2018

Last Update Submit

January 6, 2020

Conditions

Keywords

Quality of lifeResilienceCancer SurvivorsLife SatisfactionPost-Cancer DepressionCoping

Outcome Measures

Primary Outcomes (1)

  • Resilience of head and neck cancer and Brain tumor survivors

    Resilience will be measured by Wagnild \& Young's 14 Item A high score represents better resilience. The respondent's choice ranges from 1 (Strongly Disagree) to 7 (Strongly Agree). The scale uses total scores rather than scores of individual items.

    April 2018-March 2019

Secondary Outcomes (1)

  • Quality of life of head and neck cancer and Brain tumor survivors

    April 2018-March 2019

Interventions

Non applicable

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Men and women greater than 18 years, who have received treatment for brain tumor and head \& neck cancer, fulfilling the below eligibility criteria.

You may qualify if:

  • Individual aged \> 18 years both gender
  • Had received treatment at AKUH for head \& neck cancer and/or brain tumor.
  • Pakistani national currently living in Pakistan.

You may not qualify if:

  • Known cases of any physical and/or psychiatric illness (manic disorder, schizophrenia etc.) confirmed by medical records will be excluded from the study as they may be on medications, hence we may not get the true results.
  • Patients on anti-depressants prescribed by a psychiatrist.
  • Participant with terminal disease like renal failure and stroke will be excluded because these diseases also have profound effect on quality of life and resilience.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aga Khan University

Karachi, Sindh, 74800, Pakistan

Location

Related Publications (1)

  • Zahid N, Khalid W, Ahmad K, Bhamani SS, Azam I, Asad N, Jabbar AA, Khan M, Enam A. Resilience and quality of life (QoL) of head and neck cancer and brain tumour survivors in Pakistan: an analytical cross-sectional study protocol. BMJ Open. 2019 Sep 20;9(9):e029084. doi: 10.1136/bmjopen-2019-029084.

MeSH Terms

Conditions

Personal Satisfaction

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Instructor Research

Study Record Dates

First Submitted

March 1, 2018

First Posted

March 15, 2018

Study Start

November 1, 2018

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

January 9, 2020

Record last verified: 2020-01

Locations