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CompletedNCT03466762Updated Jan 9, 2020

Resilience and Quality of Life Among Cancer Survivors

An observational study in Mental Health Wellness 1, sponsored by Aga Khan University. Completed at 1 site in Pakistan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-09.

Sponsored by Aga Khan University · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
500
Ages
18 Years and older
Sex
All
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Study 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.

Read the detailed description

Background In 2012, around 14.1 million new cases of cancer were diagnosed worldwide and another 8.2 million died from cancer. It is estimated that by 2030, these figures could increase to an alarming 26.4 million new cases and 17 million cancer-related deaths. Nearly 56% of the new cancer cases and 64% of the cancer-related deaths occur in low and middle income countries (LMICs), where there is a lack of universally available, affordable, and sustainable health care. Head and neck cancers are among the most common cancers worldwide with nearly 600,000 new cases and 300,000 deaths occurring globally every year. Brain tumors are responsible for approximately 2% of all cancer deaths. The overall incidence of brain tumors is 4-5/100,000 population per year. Cancer's diagnosis considerably affects patient's emotional and psychological status. The cancer survivors encounter various challenges, as they battle to maintain an optimistic outlook towards life. Resilience enables individuals to thrive in the face of adversity and it is believed that resilience plays an important role in a cancer survivor's life to cope with their illness, to overcome depression and improve their Health- related quality of life (HR-QoL). HR-QoL and its assessment have become increasingly important in health care, especially in the field of chronic diseases recently. HR-QoL generally refers to patients' perceptions of the effects of disease on life. It has two fundamental premises; first, a multi-dimensional concept incorporating physical, psychological, social, and emotional functional domains. Second is subjective and must be self-reported, according to the patients' own experiences. Conventionally, the endpoints of medical care for cancer patients had focused on survival rate, local control rate, or complication rate. However, assessments have lacked knowledge and understanding of the patient's mental and emotional wellbeing. Recently, resilience in the course of cancer treatment has been given immense attention. Several studies from different parts of the world on cancer survivors suggest that resilience is a protective factor for distress. A study reported resilience was likely to mediate the adverse relationship between cancer symptoms, distress and QoL for cancer survivors, indicating, resilience might play an essential role in protecting against adverse effects of cancer symptoms on QoL. It is identified, that resilience as an important changeable path can improve hope and QoL. Therefore, it is important that before initiating treatment, patients should be referred to a mental health professional for psychological/psychiatric evaluation. Resilience and QoL is a critical component during diagnosis, treatment, survivorship, and at the end of life. Hence, these are important traits for promoting positive psycho-social well-being. Resilience and QoL changes over time and may be modifiable towards increased well-being. To the best of the investigators knowledge, this will be the first in-depth study to evaluate resilience and quality of life among head \& neck cancer and brain tumor patients in Pakistan. Moreover, through this study the investigators will be able to identify problems faced by such patients in their setting, enabling the investigators in the future to design interventions to improve resilience and QoL.

02

Conditions studied

  • Mental Health Wellness 1

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Keywords

  • Quality of life
  • Resilience
  • Cancer Survivors
  • Life Satisfaction
  • Post-Cancer Depression
  • Coping
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In context

Personal Satisfaction

541 studies on the registry are indexed under Personal Satisfaction; 93 are open to participants now.

This study's enrollment of 500 is above the median of 180 across 115 observational studies indexed under Personal Satisfaction.

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Lead sponsor

Aga Khan University is the lead sponsor of 294 studies on the registry; 43 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria

  1. 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.
  2. Patients on anti-depressants prescribed by a psychiatrist.
  3. 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.
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Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
500 participants (actual)
Patient registry
No

Interventions

  • OtherNon applicable

    Non applicable

06

What researchers measure

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.

    Time frame: April 2018-March 2019

Secondary outcomes

  1. Quality of life of head and neck cancer and Brain tumor survivors

    Quality of life will be measured by European Organization of Research and Treatment Of Cancer tool general (EORTC QLQ-C30) AND European Organization of Research and Treatment Of head and Neck cancer (EORTC QLQ-H\&N35) AND European Organization of Research and Treatment Of Brain tumor ( EORTC QLQ-BN20) All of the scales and single-item measures scores range from 0 to 100. A high scale score represents a higher response level.

    Time frame: April 2018-March 2019

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Study locations

1 site
  • Aga Khan University
    Karachi, Sindh 74800, Pakistan
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References and documents

Publications

  • 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. PubMed 31542743 ↗

Individual participant data

Plan to share: Undecided

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2018 to primary completion in Jun 2019, 7 months.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 1, 2018
First posted
Mar 15, 2018
StartActual
Nov 1, 2018
Primary completionActual
Jun 30, 2019
CompletionActual
Jun 30, 2019
Last update
Jan 9, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 9, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03466762
Responsible party
Nida Zahid (Senior Instructor Research, Aga Khan University) — Principal investigator
First posted
Mar 15, 2018
Start date
Nov 1, 2018
Primary completion
Jun 30, 2019
Completion
Jun 30, 2019
Last update
Jan 9, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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