Mental Health Wellness 1NCT03466762
Resilience and Quality of Life Among Cancer Survivors
An observational study of Mental Health Wellness 1, run by Aga Khan University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Health Wellness 1
- What is being tested?
- Non applicable
- How many people
- 500 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2018to 30 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Resilience and Quality of Life of Head & Neck Cancer and Brain Tumor Survivors in Pakistan
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:
Read more
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.
- Conditions
- Mental Health Wellness 1
- Being tested
- Non applicable
- Keywords
- Quality of life, Resilience, Cancer Survivors, Life Satisfaction, Post-Cancer Depression, Coping
- Medical subject headings
- Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non applicableOther
Non applicable
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: April 2018-March 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2018
- Study start1 Nov 2018
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental Health Wellness 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nida Zahid, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03466762
- Sponsor's protocol ID
- 5154-Sur-ERC-17
- Status last verified
- Jan 2020
- First submitted
- 1 Mar 2018
- Last updated
- 9 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resilience and Quality of Life of Head & Neck Cancer and Brain Tumor Survivors in Pakistan
- ClinicalTrials.gov ID
- NCT03466762
- Acronym / sponsor ID
- 5154-Sur-ERC-17
- Conditions
- Mental Health Wellness 1
- Keywords
- Quality of life, Resilience, Cancer Survivors, Life Satisfaction, Post-Cancer Depression, Coping
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 15 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non applicableNon applicable | Other | – |
Primary outcome
Resilience of head and neck cancer and Brain tumor survivors
Time frame: April 2018-March 2019
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.
1 secondary outcome
Quality of life of head and neck cancer and Brain tumor survivors
Time frame: April 2018-March 2019
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2020.
- Derived from this study: PubMed 31542743Zahid 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Health Wellness 1, run by Aga Khan University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resilience of head and neck cancer and Brain tumor survivors (time frame: April 2018-March 2019). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03466762, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2020.